Intervention Review

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Anti-D administration after spontaneous miscarriage for preventing Rhesus alloimmunisation

  1. Laxminarayan Karanth1,*,
  2. Sharifah Halimah Jaafar2,
  3. Sachchithanantham Kanagasabai1,
  4. N S Nair3,
  5. Ankur Barua4

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 28 MAR 2013

Assessed as up-to-date: 15 FEB 2013

DOI: 10.1002/14651858.CD009617.pub2


How to Cite

Karanth L, Jaafar SH, Kanagasabai S, Nair NS, Barua A. Anti-D administration after spontaneous miscarriage for preventing Rhesus alloimmunisation. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD009617. DOI: 10.1002/14651858.CD009617.pub2.

Author Information

  1. 1

    Melaka Manipal Medical College, Department of Obstetrics and Gynecology, Melaka, Malaysia

  2. 2

    Ipoh Specialist Hospital, Department of Obstetrics and Gynaecology, Ipoh, Perak, Malaysia

  3. 3

    Manipal University, Department of Statistics, Manipal, Karnataka, India

  4. 4

    International Medical University (IMU), Department of Community Medicine, Kuala Lumpur, Malaysia

*Laxminarayan Karanth, Department of Obstetrics and Gynecology, Melaka Manipal Medical College, Bukit Baru, Jalan Batu, Hampar, Melaka, 75150, Malaysia. karanthkl@ymail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 28 MAR 2013

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Characteristics of included studies [ordered by study ID]
Visscher 1972

MethodsRandomised control trial.


Participants57 eligible Rh-negative women who had had spontaneous miscarriage at gestation 8-24 weeks consented to participate in the study.

9 dropped out pre intervention and no reason was stated.

48 participants randomly received injection of coded ampules within 72 hours of spontaneous miscarriage.

19/57 treatment group: 14/19 had dilatation & curettage (therapeutic dilatation & curettage), 5/19 had spontaneous miscarriage.

29/57 control group: 25/29 had dilatation & curettage (therapeutic dilatation & curettage), 4/29 had spontaneous miscarriage.


InterventionsIntervention: IM 300 µg Rhesus anti-D immunoglobulin in a coded ampule.

Control: IM 1 mL of homogenous gamma globulin placebo in a coded ampule.

The coded ampoules were randomly assigned to the eligible participants and both the participants and the clinicians were blinded.

Blood was collected after 6 months and the code was revealed. About 19/57 participants received 300 µg of Rhogam and 29/57 participants received 1 mL of homologous gamma globulin placebo.


OutcomesAt 6 months follow-up, in the treatment group all 19 were non-sensitised as evidenced by indirect Coombs' test.

In subsequent follow-up, 3 Rh +ve non-sensitised pregnancies were observed.

On 6 months follow-up in control group, all 29 were non-sensitised evidenced by indirect Coombs' test.

In subsequent follow-up, 6 Rh +ve non-sensitised pregnancies were observed.


NotesABO incompatibility and parity were not mentioned.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskDouble blind study with coded ampules. The ampules were randomly assigned to the eligible participants. However, it is not clear how the sequence of the code were generated and how randomisation of the participants was done.

Allocation concealment (selection bias)Low riskThe ampules containing 300 µg Rh immunoglobulin and gamma globulin placebo were coded and all ampules were homogenous.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskThe clinician and the participants were both blinded from pre intervention up to 6 months post intervention when the codes were broken.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskSerology tests were done for both groups to detect atypical blood group antibody by indirect Coombs test and the code was revealed. Subsequently onwards, having known who received anti-D or placebo, the outcome of subsequent Rh-positive pregnancy was anticipated.

Incomplete outcome data (attrition bias)
All outcomes
High riskAll participants were followed up post-intervention. Of 18/57 subsequent pregnancies, 3/19 from the treatment group and 6/29 from the control group reported Rh-positive pregnancies.

Selective reporting (reporting bias)High riskIt is not known whether or not the other 39/57 participants ever got pregnant with a Rh-postive pregnancy and what was the outcome after the follow-up period was over. While it is clear that the recruitment was terminated at 2 years, it is not clear how long each of the participants from both groups were followed up in order to see the outcome of the subsequent Rh-positive pregnancy.

Other biasUnclear riskNot noted.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Keith 1977All participants in the trial received anti-D. One study arm received micro dose 50 µg anti-D compared with other arm that received a standard dose 300 µg anti-D. Thus, there was no comparison with non-intervention group as prespecified in the review.

 
Comparison 1. Adverse pregnancy outcome following anti-D administration following spontaneous miscarriage

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

1 Adverse reaction00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Antibody D titre at 6 months following administration (non-prespecified outcome)148Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 3 Rh isoimmunisation in subsequent pregnancies following anti-D administration19Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

4 Health of infant in subsequent pregnancy00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

5 Positive Kleihauer test after miscarriage before 14 weeks' gestation00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

6 Positive Kleihauer test after miscarriage following 14 weeks' gestation 00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

7 Need for increased fetal surveillance for suspected isoimmunisation in subsequent pregnancies00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]