Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

NCT02438371 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-15-0134
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Conditions

Preterm Labor

Keywords

pregnancy; preterm labor; tocolysis

Outcome Measures

Primary Outcomes (1)

• Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation

  48 hours after administration of tocolytic agent

Secondary Outcomes (27)

• Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation

  7 days after administration of tocolytic agent

• Number of Days From First Dose of Tocolytic Agent to Delivery

  from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

• Neonatal Birthweight

  at the time of birth

• Neonatal Sex

  at the time of birth

• Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)

  from birth until hospital discharge or day 120 of life (whichever occurs first)

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours.

Drug: Nifedipine

Nifedipine plus Indomethacin

ACTIVE COMPARATOR

Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours.

Drug: Nifedipine; Drug: Indomethacin

Interventions

Nifedipine DRUG

Also known as: Procardia

Nifedipine; Nifedipine plus Indomethacin

Indomethacin DRUG

Nifedipine plus Indomethacin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
• cervical change of at least 1 cm or
• cervical dilation of 2 cm at the time of initial exam or
• positive fetal fibronectin and transvaginal cervical length \<2.5 cm

You may not qualify if:

• We will exclude pregnant women with any contraindication to tocolysis:
• clinical chorioamnionitis (defined as a temperature of \>100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
• non reassuring fetal heart tones
• suspected placental abruption
• preterm premature rupture of membranes
• prior tocolytic treatment during the past 48 hours
• known adverse effect to indomethacin or nifedipine
• already receiving nifedipine for chronic hypertension

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, 77030, 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

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Jerrie S. Refuerzo, MD
• Organization: The University of Texas Health Science Center at Houston

Jerrie.S.Refuerzo@uth.tmc.edu

(713) 500-6416

Study Officials

• Maria Hutchinson, M.S.

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)