Two Dose Regimens of Nifedipine for the Management of Preterm Labor

This study has been terminated.
(The trial was terminated because of difficulties in recruitement.)
Sponsor:
Information provided by (Responsible Party):
Anwar Nassar, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00137501
First received: August 29, 2005
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.


Condition Intervention Phase
Labor, Premature
Drug: Nifedipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Different Doses of Nifedipine to Treat Preterm Labor

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Uterine quiescence at 48 hours of initiation of tocolysis [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Speed of uterine quiescence, remaining undelivered at >48 hours and >7 days after tocolysis, delivery <34 and 37 weeks of gestation, hours to quiescence, gestational age, maternal drug reactions, hospital stay, neonatal morbidities &neonatal death. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: May 2003
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
High dose Nifedpine arm
Drug: Nifedipine

Arm A:

Nifedipine 20 mg sublingual, repeated after 30 minutes if contractions do not decrease in intensity. Maintenance of 120-160 mgs of slow-release nifedipine daily for 48 hours.Once contractions cease, nifedipine will be maintained at 80-120 mg daily in divided doses up to 36 weeks.

Arm B:

Nifedipine 10 mg sublingual crushed, then 10 mg in 15 min, followed by 10 mg PO Q 15 mins PRN to a maximum of 40 mg in the first hour. Maintenance of 60-80 mgs of slow-release nifedipine daily for 48 hours. Once contractions cease, nifedipine will be maintained at 60 mg daily in divided doses up to 36 weeks.

Other Name: Adalat, Nifedicor
B
Low dose Nifedipine arm
Drug: Nifedipine

Arm A:

Nifedipine 20 mg sublingual, repeated after 30 minutes if contractions do not decrease in intensity. Maintenance of 120-160 mgs of slow-release nifedipine daily for 48 hours.Once contractions cease, nifedipine will be maintained at 80-120 mg daily in divided doses up to 36 weeks.

Arm B:

Nifedipine 10 mg sublingual crushed, then 10 mg in 15 min, followed by 10 mg PO Q 15 mins PRN to a maximum of 40 mg in the first hour. Maintenance of 60-80 mgs of slow-release nifedipine daily for 48 hours. Once contractions cease, nifedipine will be maintained at 60 mg daily in divided doses up to 36 weeks.

Other Name: Adalat, Nifedicor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All pregnant women diagnosed with preterm labor defined as regular contractions associated with cervical change between 24 and 34 weeks of gestation

Exclusion Criteria:

  • Multiple pregnancy
  • Preterm rupture of membranes
  • Congenital fetal malformations
  • IUGR (intra uterine growth restriction)
  • Previous tocolysis in this pregnancy
  • Chorioamnionitis
  • Cervical dilation > 4 cms
  • Maternal medical conditions such as renal insufficiency, hepatic insufficiency, or myasthenia gravis
  • Non-reassuring fetal heart rate
  • Maternal hypotension, defined as a blood pressure < 90/50 mmHg
  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: NCT00137501

Locations
Lebanon
American University of Beirut Medical Center
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, Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00137501     History of Changes
Other Study ID Numbers: OGY.AN.01
Study First Received: August 29, 2005
Last Updated: July 18, 2013
Health Authority: Lebanon: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 29, 2014