Last reviewed · How we verify
NCT03039036
Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
NA trial testing Amniotomy in Labor Induction in 69 participants. Completed in 1 December 2022.
1 December 2022
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 69 |
| Start date | 12 September 2017 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Amniotomy
- Foley Catheter
- Misoprostol (Misoprostol) — full drug profile →
Conditions studied
- Labor Induction — all drugs for Labor Induction →
Sponsor
Northwestern University
Who can join
18 and older, female only, with Labor Induction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care. The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03039036
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amniotomy
Trials testing the same drug.
- NCT05341076 — Labor Scale Versus WHO Partograph for Management of Labor (ScaLP) · NA · unknown
- NCT04906278 — Amniotomy for Second-trimester Pregnancy Termination · NA · completed
- NCT04731896 — Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 · NA · completed
- NCT04573517 — Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor · NA · completed
- NCT04216628 — Early Versus Late Amniotomy Following EAB Cervical Ripening · NA · terminated
Other recruiting trials for Labor Induction
Currently open trials in the same condition.
- NCT07006896 — Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin · NA · recruiting
- NCT07109258 — Effect of Dexamethasone on Labour Induction in Term Pregnancies · EARLY_PHASE1 · recruiting
Other Northwestern University trials
Trials by the same sponsor.
- NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies · Phase 1, PHASE2 · not yet recruiting
- NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
- NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
- NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
- NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With · NA · not yet recruiting
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 NCT03039036 (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 Northwestern University
- Last refreshed: 3 April 2023
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/NCT03039036.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing