Status:
ACTIVE_NOT_RECRUITING
Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth
Lead Sponsor:
Dr. Soetomo General Hospital
Conditions:
Pregnant Women
Pregnancies at Increased Risk of Preterm Birth
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 si...
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 arr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06975943
Start Date
January 1 2024
End Date
June 1 2025
Last Update
May 21 2025
Active Locations (1)
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1
Dr. Soetomo General Hospital Surabaya
Surabaya, East Java, Indonesia, 60286