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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 : A Randomised Clinical Trial
NA trial testing Progesterone 200 mg vaginal capsules in Pregnant Women in 48 participants. Participants enrolled and being followed up; not accepting new ones.
1 May 2025
Quick facts
| Lead sponsor | Dr. Soetomo General Hospital |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 48 |
| Start date | 1 January 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Progesterone 200 mg vaginal capsules — full drug profile →
Conditions studied
- Pregnant Women — all drugs for Pregnant Women →
- Pregnancies at Increased Risk of Preterm Birth — all drugs for Pregnancies at Increased Risk of Preterm Birth →
Sponsor
Dr. Soetomo General Hospital
Who can join
Adults 18 to 40, female only, with Pregnant Women or Pregnancies at Increased Risk of Preterm Birth. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Prolongation of Gestation Age
Time frame: Enrollment and Delivery
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. -
Changes of Cervical Length
Time frame: Enrollment, 7th and 14th day after enrollment
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06975943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Progesterone 200 mg vaginal capsules
Trials testing the same drug.
- NCT07523295 — Effect of Vaginal Progesterone Treatment on Pregnancy and Newborn Outcomes in Women With Preterm Labor · Phase 4 · completed
- NCT02225353 — Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery · Phase 2 · completed
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Other Dr. Soetomo General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06975943 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Soetomo General Hospital
- Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06975943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing