Preterm Delivery Clinical Trial
Official title:
Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate
Preterm birth remains a major cause of perinatal morbidity and mortality in developing as
well as in developed countries. Despite major clinical research efforts aimed at reducing
the incidence of preterm births in the United States, the preterm birth rate reached its
highest level in 2 decades, 11.9% in 2001, which translates to a 27% rise since 1981. Much
of this increase may be accounted for by the increase in multiple gestations brought about
by assisted reproductive technology. Twin gestations accounting for 20% to 25% of all
pregnancies conceived following such procedures. Twin gestations are at a particularly
increased risk of preterm labor and they deliver at a mean gestational age of 37 weeks
compared to 40 weeks for singleton pregnancies. In a study by our group, we estimated that
about 54.5% of twin gestations would deliver prior to 37 completed weeks of gestation; i.e.
preterm.
Evidence regarding efficacy of interventions designed to prevent preterm birth has been
disappointing. Most well-designed clinical trials have failed to demonstrate any reduction
in preterm births with such interventions as home uterine activity monitoring, reduced
physical activity, administration of antibiotic or tocolytic therapy, and intensive and
frequent antenatal follow ups. Recently, progesterone has shown some promise in the
prevention of preterm birth among women with prior preterm births. Whether this intervention
will prove effective in other populations, such as women with multiple gestations, remains
to be seen.
The objective of our study is to compare the effectiveness of weekly intramuscular
injections of 17-alpha Hydroxyprogesterone Caproate, a natural metabolite of progesterone,
in preventing delivery at less than 37 weeks of gestation in a population of 290 patients
with twin gestations between 16 and 36 weeks of gestation compared to a placebo. The data
generated will be invaluable in managing this group of patients that is considered at a very
high risk for preterm labor and delivery.
Status | Completed |
Enrollment | 290 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Viable twin pregnancy - Current pregnancy between 16 weeks and 20 weeks of gestation Exclusion Criteria: - Known fetal anomaly in either twin - Current or planned cervical cerclage - Hypertension requiring medication - Diabetes Mellitus - Asthma - History of deep vein thrombosis - Preexisting cardiac or renal disease - A seizure disorder - Plans to deliver elsewhere - Previous or existing liver tumors - History of herpes gestationis of pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The frequency of delivery prior to completed 37 weeks of gestation (259 days). | one year | No | |
Secondary | Delivery before 35 weeks of gestation, Delivery before 32 weeks of gestation, Admission during current pregnancy for preterm labor, | 9 months | No | |
Secondary | Need for tocolytic therapy in current pregnancy, Need for corticosteroids to enhance fetal lung maturity, Route of delivery, | 9 months | No | |
Secondary | Obstetrical complications (antepartum and intrapartum) of pregnancy, Indicated preterm deliveries, Neonatal outcome variables ( Birth weight < 2500 grams, | 9 months | No | |
Secondary | Birth weight < 1500 grams, Fetal death, antepartum or intrapartum, Neonatal intensive care unit admissions, Respiratory distress syndrome, | 9 months | No |
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