Two Dose Regimens of Nifedipine for the Management of Preterm Labor
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ClinicalTrials.gov Identifier: NCT00137501 |
Recruitment Status :
Terminated
(The trial was terminated because of difficulties in recruitement.)
First Posted : August 30, 2005
Last Update Posted : July 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Labor, Premature | Drug: Nifedipine | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of Different Doses of Nifedipine to Treat Preterm Labor |
Study Start Date : | May 2003 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- Uterine quiescence at 48 hours of initiation of tocolysis [ Time Frame: 2 days ]
- 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 ]

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Ages Eligible for Study: | 17 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00137501
Lebanon | |
American University of Beirut Medical Center | |
Beirut, Lebanon |
Principal Investigator: | Anwar H Nassar, MD | American University of Beirut Medical Center |
Responsible Party: | Anwar Nassar, Professor, American University of Beirut Medical Center |
ClinicalTrials.gov Identifier: | NCT00137501 |
Other Study ID Numbers: |
OGY.AN.01 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | July 19, 2013 |
Last Verified: | July 2013 |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Nifedipine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |