Tocolysis in Prevention of Preterm Labor

September 26, 2017 updated by: mohamed atef mohamed, Assiut University

Comparative Study on Tocolysis in Prevention of Preterm Labour

Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .

Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .

A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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

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

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • . Gestational age between 24-37weeks

    • Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal discharge and vaginal spotting .
    • Regular uterine contractions at least of 30 seconds duration at a rate of more than 4/30 minutes
    • Cervical changes dilatation less than 3cm,effacement lessthan50%.
    • Intact membranes.

Exclusion criteria

  • Active vaginal bleeding and placental abruption.
  • Chorioamnionitis and intrauterine infection
  • Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction
  • Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases
  • Drug specific contraindications(contraindication of tocolysis)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulphate
Drug: Magnesium Sulfate
Those women will be given Magnesium Sulfate for tocolysis
Experimental: Ritodrine
Drug: Ritodrine
Those women will be given Ritodrine for tocolysis
Experimental: Calcium channel blocker
Drug: Calcium Channel Blockers
Those women will be given Calcium Channel Blockers for tocolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time of delivery
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

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 25, 2017

Primary Completion (Anticipated)

April 25, 2018

Study Completion (Anticipated)

May 25, 2018

Study Registration Dates

First Submitted

August 26, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPL

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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