Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

NCT03129945 | Completed Results

• 2 other identifiers: 2014-1085UC Reliance 857
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours, decrease maternal side effects and decrease some complications related to preterm delivery to the neonate. Both of these medications are commonly used to stop pre-term labor, therefore it has become our institution's standard to use these two medications in the setting of preterm labor. There have been limited studies comparing these two medications directly. A total of 450 participants will be asked to participate across all study sites.

Conditions

Obstetric Labor, Premature

Keywords

Obstetric Labor, Premature; Tocolytic Agents

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Delay of Preterm Delivery by 48 Hours.

  1\. To compare the prolongation of pregnancy by 48 hours after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The primary outcome measured will be delay of (preterm delivery) by 48 hours.

  Participants will be followed for the duration of the hospital stay, an expected average of 1 week

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

Participants will be given this medication orally

Drug: Nifedipine

Indomethacin

ACTIVE COMPARATOR

Participants will be given this medication orally

Drug: Indomethacin

Interventions

Nifedipine DRUG

Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.

Also known as: Procardia

Nifedipine

Indomethacin DRUG

Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.

Also known as: Indocin

Indomethacin

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 140 weeks by gestational age (see dating below) is acceptable.
• Gestational age at randomization between 240 weeks to 315 weeks by using the dating determinations as below
• Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular uterine contractions in 60 minutes either seen on tocodynamometer, palpated by health providers and/or subjectively felt by the patient and at least one of the following:
• Associated with cervical change by cervical dilation greater than or equal to 1cm OR effacement greater than or equal to 25 to 50%
• Cervix greater than or equal to 2cm dilated on initial digital exam
• At least 75% effaced on initial digital exam
• Short cervical length (defined by each institution's policy) as obtained by transvaginal cervical sonography \[in general, this is defined as a measurement of 2.0 - 2.5 cm or less\] and/or a positive fetal fibronectin test (defined as a level greater than 50ng/mL).
• Intact membranes
• years of age or older

You may not qualify if:

• Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops
• Maternal contraindication to nifedipine: preload cardiac lesions or maternal hypotension (systolic blood pressure less than 100 or diastolic blood pressure less than 60). A delayed dose can be given if blood pressure improves - it will be documented if dose is delayed, how long from scheduled dose it was delayed and reason for delay.
• Maternal contraindication to indomethacin: platelet dysfunction or bleeding disorders, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction and asthma
• Obstetrical contraindication to tocolysis not already mentioned: non reassuring fetal status, severe preeclampsia or eclampsia, maternal bleeding with hemodynamic instability, chorioamnionitis, preterm premature rupture of membranes
• Participation in another interventional study that influences neonatal morbidity or mortality
• Participation in this trial earlier in the pregnancy
• Maternal allergy to either indomethacin or nifedipine
• Maternal allergy to aspirin and other NSAIDs.
• Maternal hypertension requiring treatment.
• Maternal kidney disorder that would require adjustment in magnesium dosing.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• University of California, San Diego: collaborator
• University of California, Los Angeles: collaborator

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, 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

Nifedipine; Indomethacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Judith Chung
• Organization: University of California, Irvine

judithc@hs.uci.edu

714-456-8695

Study Officials

• Deborah A Wing, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Mary Norton, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Gladys (Sandy) Ramos, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Aisling Murphy, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Veronique Tache, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, Division of Maternal Fetal Medicine, Dept OBGYN

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: April 26, 2017
• Study Start: January 17, 2017
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)