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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anwar Nassar, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00141908
First received: September 1, 2005
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Preterm Delivery
Drug: 17-alpha Hydroxyprogesterone Caproate
Drug: Castor oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • The frequency of delivery prior to completed 37 weeks of gestation (259 days). [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delivery before 35 weeks of gestation, Delivery before 32 weeks of gestation, Admission during current pregnancy for preterm labor, [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Need for tocolytic therapy in current pregnancy, Need for corticosteroids to enhance fetal lung maturity, Route of delivery, [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Obstetrical complications (antepartum and intrapartum) of pregnancy, Indicated preterm deliveries, Neonatal outcome variables ( Birth weight < 2500 grams, [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Birth weight < 1500 grams, Fetal death, antepartum or intrapartum, Neonatal intensive care unit admissions, Respiratory distress syndrome, [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo progesterone injection
Placebo IM injections
Drug: Castor oil
weekly IM injections
Other Name: castor oil
Active Comparator: Progesterone injections
17-hydroxyprogesterone caproate weekly injections
Drug: 17-alpha Hydroxyprogesterone Caproate
250 mg IM weekly
Other Name: Proluton depot

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141908

Locations
Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Anwar H Nassar, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Anwar Nassar, OB-GYN, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00141908     History of Changes
Other Study ID Numbers: OGY.AN.04
Study First Received: September 1, 2005
Last Updated: July 18, 2013
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Hydroxyprogesterone Caproate, twins, preterm delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Castor Oil
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014