Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

NCT00486824 | Completed Phase 1 Results

• 1 other identifier: 97873
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective. Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.

Conditions

Obstetric Labor, Premature

Outcome Measures

Primary Outcomes (1)

• Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization

  Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.

  Two weeks after enrolled and randomized, up to 37 weeks of pregnancy

Secondary Outcomes (6)

• Neonatal Birthweight

  Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery

• Gestational Age at Delivery

  Up to 42 weeks of pregnancy

• Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery

  Up to 42 weeks of pregnancy

• Count of Participants With Neonatal Morbidity

  Up to 42 weeks of pregnancy

• Count of Participants With Side-effect Due to the Medication

  Up to 42 weeks of pregnancy

Study Arms (2)

Indomethacin

ACTIVE COMPARATOR

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

Drug: Indomethacin

Nifedipine

ACTIVE COMPARATOR

30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.

Drug: Nifedipine

Interventions

Indomethacin DRUG

One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.

Indomethacin

Nifedipine DRUG

Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Nifedipine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton and twin gestations
• Intact amniotic membranes
• No contra-indications to tocolysis
• weeks gestation by last menstrual period and/or ultrasound
• Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement

You may not qualify if:

• Ruptured amniotic membranes
• Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
• Non-reassuring fetal heart rate tracings
• Contra-indications to indomethacin or nifedipine
• Contra-indications to tocolysis

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Indomethacin; Nifedipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The sample size for the analysis was not reached.

Results Point of Contact

• Title: Dr. Deirdre Lyell
• Organization: Stanford University

dlyell@stanford.edu

6507255720

Study Officials

• Deirdre Judith Lyell

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 15, 2007
• Study Start: April 1, 2007
• Primary Completion: December 8, 2012
• Study Completion: December 8, 2012
• Last Updated: October 1, 2018
• Results First Posted: October 1, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)