Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Obstetric Labor, Premature Clinical Trial

Official title:

Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486824
• Other study ID #: 97873
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2007
• Est. completion date: December 8, 2012

Study information

• Verified date: August 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients presenting between 24-34 weeks gestation 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. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 8, 2012
• Est. primary completion date: December 8, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Singleton and twin gestations

• Intact amniotic membranes

• No contra-indications to tocolysis

• 24-34 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neonatal Birthweight	Birthweight is presented in grams	Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery
Secondary	Gestational Age at Delivery		Up to 42 weeks of pregnancy
Secondary	Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery		Up to 42 weeks of pregnancy
Secondary	Count of Participants With Neonatal Morbidity	Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.	Up to 42 weeks of pregnancy
Secondary	Count of Participants With Side-effect Due to the Medication	Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.	Up to 42 weeks of pregnancy
Secondary	Time to Uterine Quiescence	Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.	Up to 42 weeks of pregnancy