CTRI/2008/091/000157.
Trial name or title | A clinical trial to study the effect of injection of anti‐D administered during pregnancy for Rh‐negative mothers. |
Methods | Randomised controlled trial. |
Participants | Recruitment target: 100 women. Setting: Dr TMA Pai Rotary Hospital, Karkala, India. Inclusion criteria: all Rh‐negative and indirect agglutinin test negative primigravida and un‐sensitised multigravida who are willing to participate in the study. Exclusion criteria: all Rh‐negative mothers with Rh‐negative husbands. Indirect agglutination test positive. |
Interventions |
Treatment group: antenatal administration of 300 µg (1500 IU) of Rh‐D immunoglobulin. Control group: no intervention. |
Outcomes |
Primary outcomes: incidence of immunisation during pregnancy at term, at delivery and at 6 months. Secondary outcomes: incidence of neonatal hyperbilirubinaemia, need for exchange transfusion, and need for phototherapy. |
Starting date | 1/12/2008 on the trial registry however, the trial is listed as "not yet recruiting". |
Contact information |
Scientific queries: Dr AP Manjunath Associate Professor Department of Obstetrics and Gynaecology 576104, India Phone: 09845913140 Fax: 080257061 Email: manjunanth.ap@manipal.edu |
Notes |
IU: international units