Ectopic pregnancy and miscarriage Should anti-D rhesus prophylaxis be given to women with a threatened miscarriage, miscarriage or ectopic pregnancy 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 abortion 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 pregnancies. 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.