Short-Term Tocolysis in Preterm Labor

July 6, 2026 updated by: Mohamed Taleb Hussein Abdellattif, Sohag University

Prognostic Factors Affecting the Success of Short-Term Tocolysis in Preterm Labor

The aim of this study is to identify independent prognostic factors associated with the success of short-term tocolysis, defined as delivery delayed by at least 48 hours, in women with singleton preterm labor

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

All participants will receive short-term tocolytic therapy according to the unit protocol.

  • The choice of tocolytic agent (., Magnesium sulphate ) will be determined by the treating physician.
  • Tocolysis will be administered for a maximum duration of 48-72 hours.
  • Antenatal corticosteroids (Betamethasone amp 12mg once daily for 2days) will be administered to eligible participants to enhance fetal lung maturity.
  • Failure documented when there is efficient uterine contractions more 4/10mins each one lasts more than 40 seconds, and there was progressive cervical dilatation more 3cm

Study Type

Observational

Enrollment (Estimated)

100

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants will receive short-term tocolytic therapy according to the unit protocol.

  • The choice of tocolytic agent (., Magnesium sulphate ) will be determined by the treating physician.
  • Tocolysis will be administered for a maximum duration of 48-72 hours.
  • Antenatal corticosteroids (Betamethasone amp 12mg once daily for 2days) will be administered to eligible participants to enhance fetal lung maturity.
  • Failure documented when there is efficient uterine contractions more 4/10mins each one lasts more than 40 seconds, and there was progressive cervical dilatation more 3cm

Description

Inclusion Criteria:

  • Age from 18 to 45 years old.
  • Singleton Pregnancy
  • Gestational age between 24 and 34 weeks, confirmed by last menstrual period and/or first-trimester ultrasound.
  • Diagnosis of preterm labor, defined as Regular uterine contractions (≥4 in 20 minutes recorded in CTG) with a documented change in cervical dilation (e.g., from<1 cm to ≥2 cm) or, in nulliparous women, a dilation of ≥2 cm
  • Intact membranes at the time of presentation.

Exclusion Criteria:

Established preterm labor (efficient uterine contractions 4/10mins each one lasts more than 40 Seconds recorded in CTG, with cervical changes (dilatation>4cm, effacement>80%)).

  • Evidence of chorioamnionitis or intrauterine infection.
  • Preterm premature rupture of membranes (PPROM).
  • Maternal medical disorders contraindicating tocolysis, such as severe preeclampsia, significant cardiac disease, or uncontrolled diabetes mellitus.
  • Contraindications to continuation of pregnancy, including placental abruption or placenta previa with bleeding.
  • Vaginal bleeding of unknown origin" as a specific exclusion criterion, as it may indicate abruption or other pathologies.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful short-term tocolysis, defined as postponement of delivery for at least 48 hours after initiation of tocolytic therapy
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Sohag University

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-6-26MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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