Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate

NCT00141908 | Completed Phase 2

• 1 other identifier: OGY.AN.04
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Delivery

Keywords

Hydroxyprogesterone Caproate, twins, preterm delivery

Outcome Measures

Primary Outcomes (1)

• The frequency of delivery prior to completed 37 weeks of gestation (259 days).

  one year

Secondary Outcomes (4)

• Delivery before 35 weeks of gestation, Delivery before 32 weeks of gestation, Admission during current pregnancy for preterm labor,

  9 months

• Need for tocolytic therapy in current pregnancy, Need for corticosteroids to enhance fetal lung maturity, Route of delivery,

  9 months

• Obstetrical complications (antepartum and intrapartum) of pregnancy, Indicated preterm deliveries, Neonatal outcome variables ( Birth weight < 2500 grams,

  9 months

• Birth weight < 1500 grams, Fetal death, antepartum or intrapartum, Neonatal intensive care unit admissions, Respiratory distress syndrome,

  9 months

Study Arms (2)

Placebo progesterone injection

PLACEBO COMPARATOR

Placebo IM injections

Drug: Castor oil

Progesterone injections

ACTIVE COMPARATOR

17-hydroxyprogesterone caproate weekly injections

Drug: 17-alpha Hydroxyprogesterone Caproate

Interventions

17-alpha Hydroxyprogesterone Caproate DRUG

250 mg IM weekly

Also known as: Proluton depot

Progesterone injections

Castor oil DRUG

weekly IM injections

Placebo progesterone injection

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Viable twin pregnancy
• Current pregnancy between 16 weeks and 20 weeks of gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Premature Birth

Interventions

17-alpha-Hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; Castor Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Anwar H Nassar, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OB-GYN

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: October 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

LE (1)