Ectopic and miscarriage

Should anti-D rhesus prophylaxis be given to women with a threatened miscarriage, miscarriage or in the first trimester?

Study details Participants Interventions Methods Outcomes and Results Comments

Full citation Sample size Interventions Details Results Limitations

Visscher,R.D., N=57 Rhogam (300 All women admitted to Grand STUDY PART 1: TRIAL OF Method of randomisation not Visscher,H.C., Do micrograms) Rapids hospitals with a RHOGAM VS. PLACEBO reported. Rh-negative women (Note: 48 women (n=19) diagnosis of miscarriage were with an early participated in the double- interviewed by a registered Evidence of sensitisation Unclear that treatment spontaneous blind part of the study; 9 nurse, who obtained the patient's (number/total (%)) allocation would be concealed need Rh immune Placebo participated in the second (homologous obstetric history and miscarriage and blinding maintained, if one prophylaxis?, part of the study, without information, explained the a. At 6 months ampule contained 300 American Journal of gamma intervention) globulin) project and gained consent. The micrograms of anti-D and the Obstetrics and nurse also drew the blood Rhogam: 0/19 other contained 1 ml of gamma Gynecology, 113, (n=29) Characteristics samples and gave all injections. Placebo: 0/29 globulin. 158-165, 1972 Women matching the inclusion No intervention criteria were included in the (Note: 12 of the 19 who received Small sample size in both parts

Ref Id Gestational age/weeks (n=9) study, which had two parts. Rhogam had evidence of passive of the trial, and particularly for (range): 8 - 24 During the study period, 1084 antibody from the treatment, but this follow-up of later . 126397 No further details are given, women were admitted with a had disappeared by 6 months after apart from that the majority diagnosis of miscarriage, of injection) An unknown proportion of Country/ies where were between 8 and 16 which 65 were Rh- and non- women had gestational ages the study was weeks gestation, by dates. sensitised, and 57 consented to outside the scope of the carried out b. In a later Rh+ pregnancy participate. guideline. USA Type of miscarriage, split by Rhogam: 0/3 (0) intervention The first part of the study was a Placebo: 0/6 (0) Other information Study type received (number/total (%)) double blind study comparing

anti-D administration and STUDY PART 2: FOLLOW-UP OF Complete miscarriage placebo, in which 48 women Two part study: - Rhogam: 5/19 PATIENTS WITH NO participated. Coded ampules INTERVENTION - Placebo: 4/29 contained either 300 micrograms 1. double blind trial of - No intervention: 0/9 of Rh immune globulin (supplied Rhogam vs. placebo as RhoGAM by the Ortho Evidence of sensitisation Incomplete miscarriage with Research Foundation) or 1 ml of (number/total (%)) 2. case series, curettage homologous gamma globulin following women - Rhogam: 14/19 with no demonstrable Rh (D) a. At 6 months: 0/9 (0) without intervention - Placebo: 25/29 antibody. Women were then injected intramuscularly with the b. In a later Rh+ pregnancy: 0/2 (0)

605 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Aim of the study - No intervention: 9/9 contents of one of the randomly selected coded ampules, within To determine the risk Inclusion criteria 72 hours after a spontaneous of sensitisation after complete miscarriage or a miscarriage surgical completion of an Diagnosis of miscarriage, incomplete miscarriage. The confirmed by either: results of the double blind study Study dates - Histopathologic were evaluated after 2 years, confirmation of the products and as there was no evidence of July 1968 to March of conception by a isoimmunisation, it was 1971 pathologist or obstetrician, terminated. or - A reliable history of vaginal During the second part of the Source of funding bleeding and cramping study, 9 women were followed associated with the passing as controls, with no one Supported by a grant of products of conception receiving any injection. All 9 had from the John A. occurring in a woman who received a D&C for incomplete Hartford Foundation had missed at least one miscarriage. Inc., New York, menstrual period and had a through the Blodgett prior diagnosis of pregnancy Follow-up Memorial Hospital established by pelvic Research examination or lab test All 57 women were followed up Department. for 6 months. Sera was obtained Rh- and not immunised to at 3 and 6 months from any of the blood group all patients, and screened for the antigens, as determined by presence of atypical antibodies. the absence of immune Subsequent pregnancies were antibodies in their sera at then studied for clinical and the time of miscarriage serological evidence of Rh isoimmunisation. Samples from Rh+ fathers pre-injection and follow-up samples were labelled, frozen Exclusion criteria and stored for future reference and to confirm any primary Not reported immune response.

All sera were screened for atypical antibodies in two ways. The initial screen was performed with the Indirect Coombs test. At

606 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

3 month intervals, all frozen stored sample were evaluated with an enzyme-Coombs screening procedure. The screening cells were incubated for 15 minutes at 37 degrees in 1% solution of trypsin in buffer. The 4% cell suspension was washed three times with saline and reconstituted to its original volume with buffered saline. The screening with the trypsinised cells was conducted in the same manner as non-trypsinised cells. The technique increases sensitivity 10 times. Full citation Sample size Interventions Details Results Limitations

Simonovits,I., N=397 Some women The study reports data from Rates of immunisation at the end of Women were sensitised after Bajtai,G., Kellner,R., received 50 women in their second the second pregnancy (number/total an induced abortion, and Kerenyl,M., Rucz,L., (however 156 of these had a micrograms of pregnancy, split into two groups: (%)) therefore are not our exact Szilvas,R., Takacs,S., pregnancy that ended in anti-D IgG after population of interest. Immunization of delivery and did not receive the first induced - Women who received 50 RhO(D)-negative a. in women who were given anti-D anti-D. Their outcomes are abortion (n=96) micrograms of anti-D following a following their induced abortion: 1/96 Unclear if the fathers were Rh+ secundigravidae reported in another included first trimester abortion in their and therefore whether they whose first pregnancy (1.0) study. Therefore, the Some women first pregnancy were actually at risk of was terminated by population of interest for this did not receive sensitisation induced abortion, (Note: this woman delivered a baby review is N=241) any prophylaxis - Women who were not at the end of her second pregnancy; Haematologia, 8, after the first protected after the first abortion, The sensitisation in the woman 291-298, 1974 therefore it is likely that she became Characteristics induced and whose second pregnancy immunised during the pregnancy. who received anti-D is likely to abortion terminated in induced abortion, have occurred during the Ref Id The evidence of sensitisation was (n=301) miscarriage, or delivery during from a positive papain-treated RBC second pregnancy - she tested Outcome of second the study period negative in February and May 126740 pregnancy test at the end of the second pregnancy. ICT result is not reported. of the year that she became The serological tests were made pregnant and gave birth Country/ies where This woman had also tested negative a. In those who received immediately after the obstetric (November). the study was using ICT and papain-treated RBC anti-D after first abortion event and then three to six carried out about 6 months before birth) months later. All the women Other information Induced abortion: 53/96 were reported to be negative for

607 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Hungary (55.2) immunisation before their first b. in women who were not given anti- This study population overlaps Miscarriage: 3/96 (3.1) abortion. D following their induced abortion: with the population of

Study type Delivery: 39/96 (40.6) 2/145 (1.4) Simonovits et al. 1980. No further methodological details Therefore, outcomes in women Prospective, b. In women who did not are given. (Note: out of those sensitised, 1 who were not protected and observational study received anti-D after first woman had a miscarriage and 1 whose pregnancies ended in abortion woman had an induced abortion in delivery will not be reported in their second pregnancy. The former Aim of the study this study, as they are reported Induced abortion: 121/301 had a positive test result using elsewhere. (40.2) papain-treated RBC (1:256) and ICT To clarify the Miscarriage: 24/301 (8.0) (1:128). The latter had received an frequency of antibody Delivery; 156/301 (51.8) intramuscular blood injection in formation during the childhood, and no details are given second pregnancy in regarding her particular test results) women whose first Inclusion criteria pregnancy was interrupted in the first Rh-D negative trimester. Secundigravidae Study dates Previous pregnancy ended by first trimester induced 1971 to 1973 abortion

Source of funding Exclusion criteria

None stated Not reported Full citation Sample size Interventions Details Results Limitations

Katz,J., Marcus,R.G., Prospective study: N=36 N/A Prospective study PROSPECTIVE STUDY Prospective study Incidence of Rh - Miscarriage was up to 20 immunization Retrospective study: N=208 36 patients were investigated Presence of Rh antibody at 5 months weeks; therefore some are following abortion: (however only 25 of them following curettage for a after miscarriage (number/total (%)) outside the scope of this possible detection of had a previous abortion, and miscarriage of less than 20 guideline lymphocyte priming to therefore are the population weeks gestation. Kleihauer fetal All patients: 1/36 (2.8) - Study was conducted in Rh antigen, American of interest for this review) cell counts were performed South Africa and no Journal of Obstetrics within 48 hours of the surgery, Primigravidas only: 0/17 (0) characteristics of the and Gynecology, 117, and tests for rosette immunocyto population are reported

608 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

261-267, 1973 Characteristics adherence and the presence of Multigravidas only: 1/19 (5.3) - Unclear which technique was plaque-forming cells (PFC) were used to test for the presence of Ref Id Of the 36 patients included carried out between day 6 and (Note: this woman had a weak antibodies, because the use of in the prospective study, 17 day 14 after the miscarriage. At antibody titre on admission and then ICT, Low's papainised cells 126795 were primigravidas and 19 the same time, Rh antibody was a titre of 1:4 at 5 months. 2 further and other techniques is were multigravidas. 24 of tested for and in 35 women, this women had a positive result using the reported in the methods Country/ies where them were known to have test was repeated 5 - 6 months rosette immunocyte adherence test) - Small sample size, N=36 the study was Rh+ husbands. later. carried out Retrospective study Retrospective study RETROSPECTIVE STUDY - Retrospective South Africa Inclusion criteria (primiparous women only) - Unclear whether the previous The findings of all Rh-negative abortion occurred in the first Study type Prospective study: primiparas admitted to the Presence of Rh antibody in women trimester. - Rh negative Queen Victoria Maternity with previous abortion/miscarriage: - In three of the sensitised This paper reports - Suffered miscarriage of a Hospital over a 3 year period 5/25 (20%) patients, it cannot be proved both a prospective pregnancy less than 20 were examined. A total of 208 that the sensitisation was and a retrospective weeks gestation patients were identified, and split (Note: it is unclear whether the definitely a result of the study - Required uterine curettage into those who were immunised women could have been sensitised in abortion/miscarriage, rather (i.e. had the Rh antibody) and the current pregnancy. However, in 2 than in the current pregnancy those who were not immunised. patients the authors state that there is Aim of the study Retrospective study: - Unclear if the previous - Rh negative primipara It was then reported whether or definite evidence of immunisation "abortion" was an abortion or a not the women had experienced following abortion/miscarriage: in one miscarriage; therefore it could Not stated a previous abortion. Results patient, the infant born after a Exclusion criteria be outside the scope of the below will be reported out of primigravida abortion was Rh- guideline Study dates those women who had a negative, and in the other patient, her - Not reported whether the None stated previous abortion. obstetric history was of three fathers were Rh+ and hence previous .) whether the women were 1968 to 1971 (for Tests used retrospective study) actually at risk of sensitisation Neonatal outcomes in sensitised - Study was conducted in Rosette immunocytoadherence women: South Africa and no Source of funding and the plaque-forming cell characteristics of the technique were used to test for - Positive direct Coombs test: 2/3 population are reported Atomic Energy Board the presence of fetal cells, but (66.7%) - Unclear which technique was that is not an outcome of interest (note: results of the test are not used to test for the presence of South African Medical for this review; therefore the reported for 2 of the infants born to antibodies, because the use of Research Council methods will not be described sensitised women; therefore the ICT, Low's papainised cells further. Rh antibody was tested denominator is 3) and other techniques is for using the indirect Coombs' reported in the methods test, enzyme treated cells (Lows - Hyperbilirubinemia/hydropic infant: papainised cells, ficin and 3/4 (75%)

609 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

trypsinised cells), albumin and (note: one woman delivered a - Small sample size, N=25 saline agglutination tests. stillborn hydropic infant; the other two had exchange transfusions Other information performed)

Full citation Sample size Interventions Details Results Limitations

Simonovits,I., N=386 None This study includes pregnant Detection of antibodies during second Women are having an induced Timar,I., Bajtai,G., women who were referred to be pregnancy (number/total (%)) abortion and therefore are not Rate of Rh Characteristics screened for Rh immunisation. exactly the population of immunization after This study only includes Rh- a. By the 2nd to 3rd month of interest for this review induced abortion, Vox secundigravidae whose first pregnancy Sanguinis, 38, 161- Not reported pregnancy was medically Women could have become 164, 1980 interrupted and who gave birth to Indirect Coombs test: 3/386 (0.8) sensitised during their second Inclusion criteria an Rh+ child at the end of her Papain-teated RBC: 6/386 (1.6) pregnancy

Ref Id second pregnancy. There were 386 women in the study period. (Note: 2 women who were positive Unclear at what point during 127379 Rh D- using papain-treated RBC were the first pregnancy the abortion The authors considered that if negative using the indirect Coombs occurred and what method Country/ies where Second pregnancy, when antibodies were detectable with test and 1 had a questionable or was used to terminate the the study was the first pregnancy had been papain-treated red blood cells unknown result, represented only as pregnancy carried out medically interrupted during the first 3 months of the a ? in the table) second pregnancy, that this was These are a discrete sub- Hungary Gave birth to a Rh D+ child at the end of the second likely to be a result of b.By the 8th to 9th month of group of the population of immunisation after the abortion. interest, in that they had to Study type pregnancy pregnancy The women who became have had a second Rh+ positive at the end of the second Indirect Coombs' test: 10/386 (2.6) pregnancy to be included. Prospective case Exclusion criteria pregnancy were considered to Papain-treated RBC: 12/386 (3.1) series be exhibiting a secondary No demographic None stated immunisation, however the (Note: the values for 8-9 months characteristics are reported for Aim of the study authors state that it is possible include those who were positive this population. that the women became earlier. 1 patients pregnancy ended in immunised during their second Not stated miscarriage before the 8-9 month Other information pregnancy. point, but she was positive for antibodies using both tests at 2-3 Study dates This population includes some No further methodological details months and therefore has been are given. women from another included included by the authors in those who study (Simonovits et al., 1974). January 1st 1971 to were positive by 8-9 months. One

610 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

June 30th 1979 patient who tested positive using Their outcomes are reported papainised cells tested negative here and will be excluded from Source of funding using ICT and one had no result the other study. listed) Not reported Full citation Sample size Interventions Details Results Limitations

Gavin,P.S., Rhesus N=57 Rhogam During the study period, 491 Incidence of sensitisations at 4 13/57 (22.8%) of women had a sensitization in (n=21) underwent therapeutic abortions months using indirect Coombs' test gestational age of over 13 abortion, Obstetrics Characteristics and 180 women were treated for (number/total (%)) weeks and therefore are and Gynecology, 39, an incomplete miscarriage. Of outside the scope of the 37-40, 1972 Placebo (n=36) these, 57 were found to be Rhogam: 0/21 (0) guideline. The sensitisations Gestational age/weeks eligible, as they were Rh- and Placebo: 2/36 (5.6) were not in this group though.

Ref Id (number/total) indirect Coombs test negative at the time of the abortion. Out of 33/57 (58%) women were 127567 4-5 Further information regarding these 57, 3 refused to sensitisations in placebo arm presenting for a therapeutic - Rhogam: 0/21 participate, 9 were lost to follow- abortion, and therefore are Country/ies where - Placebo: 1/36 up and 1 was found to have a outside the scope of this the study was Patient 1: Rh- husband. Therefore, the guideline. carried out 6-7 18 years old, Gravida 1, Para 0 remaining 44 patients were Received therapeutic abortion by - Rhogam: 0/21 combined with 13 patients Not randomised, and method USA - Placebo: 2/36 suction curettage at 81 days after identified in the same manner onset of LMP. of treatment allocation is not from a different facility. described. Method of blinding Study type Uterine size was noted to be 11 8-9 not reported. - Rhogam: 7/21 weeks gestation. All participants were given Clinical trial (not - Placebo: 14/36 Rhogam or a placebo in a 9/57 were lost to follow-up and randomised) Patient 2: double-blind manner within 72 17 years old, Gravida 1, Para 0 excluded. They were then 10-11 hours after the abortion. The replaced with women from - Rhogam: 4/21 Received therapeutic abortion by Aim of the study patients returned for a follow-up another facility. - Placebo: 8/36 suction curettage at 76 days after indirect Coombs test and onset of LMP. paternal genotype after 4 Dose of Rhogam not stated Not stated Uterine size was noted to be 10-11 12-13 months. Paternal genotypes - Rhogam: 4/21 weeks. were obtained in 50% of the Other information Study dates - Placebo: 4/36 couples, resulting in the elimination of one, as previously 14-15 November 1st 1969 stated. - Rhogam: 3/21 to August 15th 1970 - Placebo: 4/36

611 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Source of funding 16-17 - Rhogam: 1/21 Supported in part by - Placebo: 1/36 the Ortho Research Foundation and the 18-19 Kaiser Foundation - Rhogam: 1/21 Hospital - Placebo: 1/36

20+ - Rhogam: 1/21 - Placebo: 1/36

Primigravida (number/total (%))

Rhogam: 6/21 (28.6) Placebo: 12/36 (33.3%)

Method of abortion (number/total)

Spontaneous - Rhogam: 5/21 - Placebo: 5/36

Spontaneous and D&C - Rhogam: 5/21 - Placebo: 9/36

Suction - Rhogam: 8/21 - Placebo: 16/36

Saline infusion - Rhogam: 1/21 - Placebo: 0/36

D&C - Rhogam: 2/21

612 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

- Placebo: 4/36

Hysterotomy - Rhogam: 0/21 - Placebo: 1/36

Ectopic - Rhogam: 0/21 - Placebo: 1/36

Inclusion criteria

Therapeutic abortion, or surgical treatment of miscarriage

Rh- and indirect Coombs test negative at time of procedure

Exclusion criteria

Rh- husband Full citation Sample size Interventions Details Results Limitations

Murray,S., N=483 No intervention During the study period, 483 Rate of sensitisation at six months Over 80% of the whole study Barron,S.L., patients were admitted for after abortion, using different population were presenting for McNay,R.A., This is the entire study therapeutic abortion or techniques (number/total (%)) induced abortion, not Transplacental population; however only 25 miscarriage. Clinical details were miscarriage. Out of the 23 in haemorrhage after were followed-up for recorded on a serially a. Indirect Coombs' test: 1/23 (4.3) whom sensitisation was abortion, Lancet, 1, analysis of sensitisation, numbered form and blood evaluated, the proportion is 631-634, 1970 therefore they constitute the samples were labelled only with b. Low's papain: 2/23 (8.7) unknown. population of interest for this the serial number, so that fetal

Ref Id review. cell counts were carried out c. Papainised cells: 3/23 (13.0) Small sample size (only 25/483 blind. women were followed up) 128000 All of these three sensitised women Blood was collected before An unknown proportion of Country/ies where tested negative for transplacental admission where possible, and women had a gestational age

613 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments the study was Characteristics Rh antibody tests were done for haemorrhage. The details of the outside the scope of the carried out Rh- patients. At least three cases were as follows: guideline. Type of procedure samples (taken immediately UK (number/total (%)) before and after evacuation of Patient A: Received an abdominal Characteristics of the study the , and 6-48 hours later at 18 weeks gestation, population are not reported.

Study type Miscarriage: 91/483 (18.8) before discharge) were and was known to be negative at time examined for fetal cells. The of surgery. Tested positive with Blood groups of the fathers are Prospective case Induced abortion: 392/483 Kleihauer technique was used papainised cells technique only. Para not reported; therefore it is series (81.2) for fetal cell detection. 3, gravida 4. unclear whether these women - Suction curettage: 243/392 were actually at risk or not To collect direct evidence about Patient B: Received suction curettage Aim of the study (62.0) - Intra-amniotic saline: the risk of Rh isoimmunisation, at 10 weeks gestation, but was not Other information 73/392 (18.6) all Rh- patients were asked to tested for antibodies at surgery. To compare the - Abdominal hysterotomy: have another blood specimen Tested positive using Low's papain frequency of 58/392 (14.8) examined after six months, to and papainised cells techniques. transplacental - Other induced: 18/392 look for Rh antibodies. Many Para 2, gravida 3. haemorrhage in (4.6) women were reluctant to spontaneous and cooperate. Patient C: Received suction therapeutic abortion. curettage at 12 weeks gestation, and

Surgical procedures was known to be negative at time of Study dates surgery. Tested positive using all Inclusion criteria Women underwent either: three techniques. Para 3, gravida 4. November 1968 to - Suction curettage: Vacuum June 1969 Admission for therapeutic aspiration with the Kerslake abortion or miscarriage curette. This was generally followed by gentle exploration of

Exclusion criteria the with a blunt curette or ovum forceps. Source of funding - Intra-amniotic saline solution: Not reported injected into the amniotic sac United Newcastle after aspiration of clear liquor, upon Tyne Hospitals and then the uterine cavity was and Newcastle generally emptied using a Regional Hospital vacuum curette Board - Abdominal hysterotomy: in 44/58 cases this was combined with tubal ligation - Other: 8 patients had a conventional D&C and 10 had either a or a

614 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

variety of techniques

The choice of which operation to use was largely decided based on the length of gestation; therefore those at under 14 weeks were more often terminated by suction curettage. Gestation length was measured from the last recorded menstrual period.

Follow-up

Blood samples for 25 Rh- patients were examined for Rh antibodies six months after the procedure. A sensitive enzyme technique using papainised cells was used, as well as indirect antiglobulin and Low's papain techniques. In two patients, antibodies were known to have been present at the time of surgery; therefore these were excluded.

The remainder of the study population were only investigated for trans placental haemorrhage at the time of surgery, and were not followed up. Therefore, rates of sensitisation are not reported, and they do not constitute the main population of interest for this review question.

615 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Full citation Sample size Interventions Details Results Limitations

Walsh,J.J., N=200 N/A This study includes 200 women Presence of incomplete anti-D at six Small sample size Lewis,B.V., who were admitted for vaginal or months: 1/18 (5.6%) Transplacental abdominal termination of haemorrhage due to (however only 18 of these Women are having termination women had antibody pregnancy. Specimens of (Note: this was a multiparous woman of pregnancy and therefore are termination of venous blood were collected at pregnancy, Journal of measurements and whose titre rose from 1:1 immediately not the exact population of therefore constitute the the point at which the patients prior to termination to 1:256 Coombs interest Obstetrics and were admitted. The blood group of the population of interest for this after six months) review) was determined, and any Rh British negative women were checked Gestational age at which Commonwealth, 77, for the presence of antibodies. abortion was performed is not 133-136, 1970 Characteristics The presence of fetal cells was reported detected using an acid elution Ref Id Type of abortion technique. Thin and uniform Characteristics of the study (number/total) blood films were examined for population are not reported 128002 fetal cells. D&C: 29/200 Country/ies where Not reported whether the : 102/200 Vaginal termination was the study was fathers were Rh+ and Hysterectomy: 19/200 performed by cervical dilatation carried out therefore whether the women Hysterotomy: 24/200 followed by curettage or vacuum were at risk of sensitisation aspiration. Abdominal UK Intra-amniotic injection of glucose solution: 26/200 termination was performed by hysterotomy or intra-amniotic Other information Study type Inclusion criteria injections of 50% glucose solution with penicillin cover. In a The paper also reports another Prospective case selected group of patients (those case, who was not part of their series Women undergoing with uterine pathology such as study population. The patient termination of pregnancy fibroids or those undergoing was admitted in labour at 35 Aim of the study sterilisation who also suffered weeks and delivered a Exclusion criteria from menstrual dysfunction) hydropic infant. The blood termination was performed by Not reported transfusion service had hysterectomy. Not reported detected antibodies at a titre of 1:1000 albumin and the Study dates 18 Rh - women had antibody hospital lab detected anti-D tests at 6 months, using papain antibody at 1:128 albumin and Not reported and Coombs technique. Coombs in serum collected one week prior to delivery. The patient was on her second

616 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Source of funding pregnancy, and the first one had been terminated in Not reported another centre by hysterotomy at 14 weeks. There was no history of . This patient has not been reported as a case here, as she was not part of the study population. Full citation Sample size Interventions Details Results Limitations

Murray,S., N=177 N/A 177 women were admitted to Incidence of post-operative Out of the original series of Barron,S.L., Rhesus (However, only 96 were hospital for a therapeutic immunisation at approx. 6 months 177 women, 81/177 (45.6%) isoimmunization after successfully followed up and abortion or for curettage (number/total (%)) defaulted and had no post- abortion, British therefore constitute the main following a miscarriage. Samples operative specimen obtained. Medical Journal, 3, population of interest for this were collected, where possible, a. Using indirect Coombs test 90-92, 1971 review question) before and after the operation to Method of follow-up is not test for transplacental 2/96 (2.1%) reported. Ref Id Characteristics haemorrhage using the Kleihauer technique. Rh- [Note: One patient was at 12 weeks 10 of the 96 patients followed 128117 antibody tests were performed gestation and the other patient's up had not been tested before Parity (number/total (%)) with the indirect Coombs test gestational age was not known. Both the operation, including one of Country/ies where and Low's papain technique, as received a suction curettage. Both the patients who tested the study was Nulliparous: 83/177 well as by a sensitive enzyme had tested nil for antibodies pre- positive using the cellular carried out (46.9%) technique using papainised operatively] method. Of these, 48 were cells. UK successfully followed up b. Using enzyme-treated cells Indirectness of population - Wherever possible, blood includes an unknown Study type Multiparous: 94/177 samples were collected before proportion of therapeutic (53.1%) 9/96 (9.4%) the operation for such antibody abortions. It is unclear whether Prospective case Of these, 48 were followed tests, and an attempt was made [Note: This includes one patient who the sensitised patients were series up to obtain a follow-up sample six was not tested pre-operatively but having a surgical termination, months after the operation. The was known to be free of antibodies or a surgery for an incomplete Aim of the study Length of gestation/weeks maximum effort for follow-up was after her last delivery. 4 were at a miscarriage. (number/total (%)) concentrated on women with gestational age of 12 weeks or less, their first pregnancy, who would Only 44/96 women had a Not stated and 4 were at least 13 weeks. Up to 12 weeks: provide the most reliable 3 received I.A. saline, 5 had a suction gestational age of up to 12 - Followed-up: 44/96 (45.8) evidence of primary curettage and 1 had a hysterotomy] weeks. The remainder had a - Defaulted: 45/81 (55.5) immunisation. Most patients gestational age of at least 13

617 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

Study dates were followed-up between six weeks or an unknown 13 weeks: and nine months after the gestational age Not reported - Followed-up: 40/96 (41.7) procedure, however a few were - Defaulted: 31/81 (38.3) longer than this, with the longest Blood groups of the fathers are interval being 14 months. not reported; therefore it is Source of funding Not known: unclear whether these women - Followed-up: 12/96 (12.5) Out of the 96 patients are actually at risk of Research grant given - Defaulted: 5/81 (6.2) successfully followed-up, 86 had sensitisation. jointly by the United been tested before the operation Newcastle Hospitals Those who were lost to and been found to be free of Other information and the Newcastle follow-up had higher antibodies. Regional Hospital proportion of early Board gestations (12 weeks or 6 out of those immunised were less) among their reported to have no evidence primigravidae. Also, 17/81 of transplacental haemorrhage. defaulters had an abdominal 1 had <0.1 ml, 1 had 0.1 ml, hysterotomy, whereas only and 1 had no Kleihauer test 10/96 of those followed-up performed. The authors report had the operation. that transplacental haemorrhage, as detected by the Kleihauer technique, was Method of termination of no value in predicting (number/total) development of anti-D.

Spontaneous: 11/96 Number of women with Rh Suction curettage: 54/96 antibodies detected, related to Abdominal hysterotomy: amount of transplacental 10/96 haemorrhage Intra-amniotic saline: 18/96 Other methods: 1/96 None: 6/51 Not known: 2/96 < 0.1 ml: 1/13 0.1 ml: 1/7 Inclusion criteria No Kleihauer-Betke test performed: 1/26 Rh-negative women

Admitted to hospital for therapeutic abortion or for curettage following

618 Ectopic pregnancy and miscarriage

Study details Participants Interventions Methods Outcomes and Results Comments

miscarriage

Exclusion criteria

Not reported

619