NCT04404686

Vaginal Indomethacin for Preterm Labor

Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 16 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2020-05-27
• Last updated: 2020-08-11

Regulatory

• FDA-regulated drug study