Vaginal Indomethacin for Preterm Labor (TOCOMED)

August 10, 2020 updated by: Hila Hocler MD, Hadassah Medical Organization

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singe fetus
  • Gestational age between 24+0/7 and 31+6/7
  • At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
  • Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less

Exclusion Criteria:

  • Rupture of membranes
  • Vaginal bleeding
  • Cervical dilation ≥5cm
  • Known fetal malformations
  • Fetal heart rate abnormalities
  • Suspected placental abruption of adherent placental syndrome
  • Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
  • Maternal hypotension and known aortic or mitral stenosis
  • Presence of cervical cerclage
  • Previous administration of tocolytic drugs in current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Indomethacin group
Group of patients receiving Indomethacin for preterm labor treatment.
Drug: Indomethacin
Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
Other Names:
  • Indomed
ACTIVE_COMPARATOR: Nifedipine group
Group of patients receiving Nifedipine for preterm labor treatment.
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.
Other Names:
  • Pressolat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to delivery
Time Frame: through study completion, approximately 1 year
The time from administration of intervention do delivery
through study completion, approximately 1 year
Gestational age
Time Frame: through study completion, approximately 1 year
Days from last menstrual period
through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of preterm deliveries
Time Frame: through study completion, approximately 1 year
Rate of deliveries under 37+0/7 weeks of gestation
through study completion, approximately 1 year
Rate of remote from term deliveries
Time Frame: through study completion, approximately 1 year
Rate of deliveries under 34+0/7 weeks of gestation
through study completion, approximately 1 year
Rate of extreme preterm deliveries
Time Frame: through study completion, approximately 1 year
Rate of deliveries under 28+0/7 weeks of gestation
through study completion, approximately 1 year
neonatal immediate outcomes
Time Frame: through study completion, approximately 1 year
Neonatal Apgar scores
through study completion, approximately 1 year
Neonatal immediate outcome
Time Frame: through study completion, approximately 1 year
Neonatal umbilical cord pH levels
through study completion, approximately 1 year
Neonatal birth weight
Time Frame: through study completion, approximately 1 year
birth wight as recorded in chart in grams
through study completion, approximately 1 year
Neonatal outcomes
Time Frame: through study completion, approximately 1 year
neonatal intensive care unit administration rate
through study completion, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Sheba Medical Center
Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (ACTUAL)

May 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOCOMED-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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