NCT06975943

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, open-label, 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. Threatened preterm labor is characterised by rhythmic uterine contractions occurring without substantial cervical changes, as assessed through digital pelvic examination. The gestational age will be verified via ultrasound metrics and review of antenatal care documentation. All subjects will receive standard tocolytic treatment, oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. The arrest of preterm labor is characterised by a stable condition that does not advance to active labor, specifically defined as two or fewer contractions per ten minutes, intact membranes, and cervical dilatation of three centimetres or less, following a minimum of 48 hours after the first dose of tocolytics. Women will be enrolled 48 hours after tocolytic initiation. Upon obtaining written informed consent from the participants, baseline data will be collected for each individual. The baseline data comprise demographic and clinical information, including risk factors, digital pelvic examinations, and ultrasound findings. All participants will receive a digital pelvic examination to assess cervical dilation and effacement, as well as a transvaginal ultrasound to measure cervical length. Cervical length will be assessed by Ernawati at Dr. Soetomo Hospital utilising a standard procedure with a probe encased in a disposable cover, which is then inserted vaginally with an empty bladder. The cervical length will be reassessed at outpatient clinic visits at 7 days and 14 days post-enrollment. Subsequent to the acquisition of baseline data, all participants will be randomly allocated into two groups: the Control Group, which does not receive therapy, and the Therapy Group, which will receive vaginal progesterone. Ethical considerations are of utmost importance in this study. The study protocol will undergo evaluation and approval by an Institutional Review Board (IRB) or equivalent ethical committee. Confidentiality of participants will be preserved during the study, and data will be anonymised throughout analysis and reporting. All potential hazards related to the examination or drug administration will be comprehensively communicated to participants, and suitable safety protocols will be established. Participants will be notified of their right to withdraw from the study at any period without penalty.

Conditions

• Pregnant Women
• Pregnancies at Increased Risk of Preterm Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2025-05-16
• Last updated: 2025-05-21

Locations

1 site across 1 country: Indonesia