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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141908
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : July 19, 2013
Information provided by (Responsible Party):
Anwar Nassar, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: 17-alpha Hydroxyprogesterone Caproate Drug: Castor oil Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate
Study Start Date : October 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo progesterone injection
Placebo IM injections
Drug: Castor oil
weekly IM injections

Active Comparator: Progesterone injections
17-hydroxyprogesterone caproate weekly injections
Drug: 17-alpha Hydroxyprogesterone Caproate
250 mg IM weekly
Other Name: Proluton depot

Primary Outcome Measures :
  1. The frequency of delivery prior to completed 37 weeks of gestation (259 days). [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Delivery before 35 weeks of gestation, Delivery before 32 weeks of gestation, Admission during current pregnancy for preterm labor, [ Time Frame: 9 months ]
  2. Need for tocolytic therapy in current pregnancy, Need for corticosteroids to enhance fetal lung maturity, Route of delivery, [ Time Frame: 9 months ]
  3. Obstetrical complications (antepartum and intrapartum) of pregnancy, Indicated preterm deliveries, Neonatal outcome variables ( Birth weight < 2500 grams, [ Time Frame: 9 months ]
  4. Birth weight < 1500 grams, Fetal death, antepartum or intrapartum, Neonatal intensive care unit admissions, Respiratory distress syndrome, [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141908

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

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Responsible Party: Anwar Nassar, OB-GYN, American University of Beirut Medical Center Identifier: NCT00141908     History of Changes
Other Study ID Numbers: OGY.AN.04
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013
Keywords provided by Anwar Nassar, American University of Beirut Medical Center:
Hydroxyprogesterone Caproate, twins, preterm delivery
Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Castor Oil
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Gastrointestinal Agents