Nifedipine Compared to Atosiban for Treating Preterm Labor

March 12, 2012 updated by: Raed Salim

Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Israel
      • Afula, Israel, 18100
        • HaEmek Medical Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.

  2. All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:

    1. Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
    2. Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
  3. Provision of written informed consent

Exclusion Criteria:

  1. Chorioamnionitis
  2. Preterm rupture of membranes
  3. Vaginal bleeding
  4. Major fetal malformations
  5. Severe hypertensive disorders
  6. Intrauterine growth restriction (< 5th percentile).
  7. Non-reassuring fetal heart rate

  8. Maternal contraindications

    1. Chronic hypertension
    2. Systolic blood pressure < 90 mmHg
    3. Cardiovascular disease
    4. Elevated hepatic enzymes
  9. Congenital or acquired uterine malformation

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Atosiban
Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
EXPERIMENTAL: 2
Drug: Nifedipine
Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delaying labor
Time Frame: for more than 48 hours after starting treatment
for more than 48 hours after starting treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
drugs side effects
Time Frame: within the first 48 hours after treatment
within the first 48 hours after treatment
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
Time Frame: within 24 hours after delivery
within 24 hours after delivery
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
Time Frame: within 30 days from delivery
within 30 days from delivery

Collaborators and Investigators

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

Sponsor

Raed Salim

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

January 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 13, 2008

First Posted (ESTIMATE)

January 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMC070048CTIL
  • same as unique protocol ID

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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