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Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth

NCT06975943 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-21

No results posted yet for this study

Summary

This randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. The study will recruit pregnant women between 28 and 33 weeks of gestational age who had experienced threatened preterm labor at Dr. Soetomo Hospital in Indonesia. Participants will be randomly divided into two groups: a Treatment Group receiving vaginal progesterone therapy and a Control Group receiving standard care without progesterone intervention. The primary outcomes are the prolongation of gestational age until delivery and the changes in cervical length over time. The secondary outcomes are recurrence of threatened preterm labor, mode of delivery, neonatal outcomes, and survival analysis. This study will provide valuable evidence supporting the use of vaginal progesterone as an effective intervention for women at risk of preterm labor and potentially improving maternal and neonatal outcomes in Indonesia and globally. All participants will be provided with detailed information about the study, and their participation will be voluntary. Ethical considerations, including informed consent and data confidentiality, will be strictly adhered to throughout the study.

Conditions

  • Pregnant Women
  • Pregnancies at Increased Risk of Preterm Birth

Interventions

DRUG

Progesterone 200 mg vaginal capsules

Participants in this group will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. This micronized progesterone will be administered to assess its impact on pregnancy prolongation and changes of cervical length following arrested preterm labor.

Sponsors & Collaborators

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Ernawati Ernawati, Dr. · Dr. Soetomo General Hospital Surabaya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975943 on ClinicalTrials.gov