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Vaginal Indomethacin for Preterm Labor

NCT04404686 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-08-11

No results posted yet for this study

Summary

Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates.

Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.

Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.

Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study.

In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.

Conditions

  • Obstetric Labor, Premature

Interventions

DRUG

Indomethacin

Per vagina administration of 100 mg followed by a second 100 mg dosage the following day

DRUG

Nifedipine

Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Soroka University Medical Center

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Hila Hochler, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2024-04-30
Completion
2025-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404686 on ClinicalTrials.gov