Bazin B, Mandelbrot L, Parazzini F; International Conference on AIDS.
Int Conf AIDS. 1996 Jul 7-12; 11: 313 (abstract no. Tu.B.2277).
The International "MOD Trial" Group, Villejuif, France. Fax: 33-1-45 59 51 80. E-mail: b.bazin@vjf.inserm.fr.
Objectives: A large proportion of mother-to-child HIV transmission (MCT) is thought to occur during labor and delivery. However, observational studies show conflicting results regarding the effect of mode of delivery (MOD) upon MCT. The international MOD Trial group initiated an international, multicentre, randomised trial to (1) evaluate the effectiveness of elective caesarean section in decreasing MCT, (2) determine the impact of MOD on maternal morbidity and HIV progression. Method: To detect a 2-fold reduction in transmission risk (12% to 6%), 1500 pregnant women will be enrolled, taking into account differences in use of Zidovudine among trial sites and the number of women who will not have the mode of delivery to which they have been randomised. At 36 weeks of amenorrhea (or later) women who have signed informed consent and do not have a clinical indication for a caesarean section delivery are randomised in a 1:1 ratio to either elective caesarean section delivery (to take place at 38 weeks) or vaginal delivery. Women will be assessed at 6 weeks post-partum and at 6 months after delivery (clinical, hematological and immunological information). Maternal morbidity will be compared between the 2 groups. Children will be assessed at 6 weeks of age, 12 weeks and every 3 months until 18 months of age. Infant HIV infection status in the 2 groups is the primary endpoint. Trial setting: The MOD Trial is ongoing. It started first in Italy in 1993, followed by France and South Africa in June 1995. Enrollment is beginning in UK, Switzerland, Spain and Sweden. About 250 women have been enrolled to date.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Cesarean Section
- Child
- Clinical Trials as Topic
- Clinical Trials, Phase III as Topic
- Delivery, Obstetric
- Disease Transmission, Vertical
- Female
- France
- HIV
- HIV Infections
- HIV Seropositivity
- Humans
- Infant
- Italy
- Multicenter Study
- Pregnancy
- South Africa
- Spain
- Sweden
- Switzerland
- Zidovudine
- methods
- surgery
- therapy
- transmission
Other ID:
UI: 102218379
From Meeting Abstracts