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 | Active Not Recruiting DMC

• 1 other identifier: 0976/KEPK/V/2024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Interventional; Pregnant Women; Preterm Birth; Vaginal Progesterone; Indonesia

Outcome Measures

Primary Outcomes (2)

• Prolongation of Gestation Age

  This measurement will be confirmed through ultrasound parameters and review of antenatal care records for gestation age at enrollment. Then the next measurement will be at delivery. Prolongation of gestation age will be measured in days.

  Enrollment and Delivery

• Changes of Cervical Length

  This measurement will be confirmed through transvaginal ultrasound parameters at enrollment. The next measurement will be at subsequent obstetric clinic visits. Changes in cervical length will be measured in millimeters.

  Enrollment, 7th and 14th day after enrollment

Secondary Outcomes (6)

• Recurrence of Threatening Preterm Labor

  7th, 14th day after enrollment, and Delivery

• Delivery Method

  Delivery

• APGAR Score

  Delivery

• Baby Birth Weight

  Delivery

• NICU Admission

  Delivery

Study Arms (2)

Control

NO INTERVENTION

This group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will have no progesterone treatment following arrested preterm labor. Monitoring for compliance will be conducted throughout the study period.

Vaginal Progesterone

ACTIVE COMPARATOR

This group will receive standard tocolytic treatment, receiving oral nifedipine for 48 hours in conjunction with dexamethasone injections to promote fetal lung development. Participants will receive daily vaginal micronized progesterone (Microgest®) of dose 200 mg for a duration of two weeks following arrested preterm labor. Monitoring for compliance and potential side effects will be conducted throughout the study period.

Drug: Progesterone 200 mg vaginal capsules

Interventions

Progesterone 200 mg vaginal capsules DRUG

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.

Also known as: Microgest

Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnant women who have passed the acute phase of Threatened Preterm Labor that meets the following criteria:
• Persistent contractions (2-3 contractions in 10 minutes) accompanied by cervical dilation assessed based on pelvic examination (Vaginal Touche)
• Intact amniotic membrane
• Cervical dilation ≤ 2 cm
• No birth occurs within 2x24 hours since persistent contractions appear.
• Age 18-40 years
• The gestational age must be between 28 weeks and 33 weeks plus 6 days.
• Able to participate, communicate well with researchers, and willing to provide written consent to participate in the study.

You may not qualify if:

• Patients with cervical cerclage in this pregnancy
• Cervical length is less than 10 mm
• Congenital abnormalities in the fetus
• Anatomical abnormalities in the uterus
• History of antepartum hemorrhage in this pregnancy
• Known hypersensitivity to progesterone or contraindications to its use.
• Suspected or proven premature rupture of membranes at enrollment
• Subjects on drug therapy known to interact with progesterone (eg Bromocriptine, Rifampin, Ketoconazole, and Cyclosporine)
• Subjects with comorbidities: cardiovascular disease, renal function, liver function, hematological disorders, and other uncontrolled comorbidities.
• Subjects with stress conditions based on the DASS-42 questionnaire.

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead

Study Sites (1)

Dr. Soetomo General Hospital Surabaya

Surabaya, East Java, 60286, Indonesia

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Ernawati Ernawati, Dr.

  Dr. Soetomo General Hospital Surabaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

ID (1)