NCT05062343 is a NA clinical trial of Dilapan-S in Induced; Birth, sponsored by Brigham and Women's Hospital.

Who is sponsoring NCT05062343?

NCT05062343 is sponsored by Brigham and Women's Hospital.

What drugs are being tested in NCT05062343?

Interventions in NCT05062343: Dilapan-S, Cook Cervical Ripening Balloon.

What condition does NCT05062343 study?

NCT05062343 studies Induced; Birth.

Is NCT05062343 still recruiting?

NCT05062343 is currently completed. Last updated 27 October 2023.

Are results published for NCT05062343?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-27 · How we verify

NCT05062343

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Completed NA Results posted Last updated 27 October 2023

What this trial tests

NA trial testing Dilapan-S in Induced; Birth in 80 participants. Completed in 19 July 2023.

Timeline

1 May 2022

Primary endpoint
19 July 2023

19 July 2023

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	1 May 2022
Primary completion	19 July 2023
Estimated completion	19 July 2023
Sites	1 location across United States

Drugs / interventions tested

Dilapan-S
Cook Cervical Ripening Balloon

Conditions studied

Induced; Birth — all drugs for Induced; Birth →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 50, female only, with Induced; Birth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Bishop Score Primary · Up to 24 hours

Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.

Group	Value	95% CI
Dilapan-S	3.0	2.0 – 5.0
Cook Catheter	3.0	2.0 – 4.5

Patient Satisfaction Secondary · Assessed upon device removal, within 24 hours

Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).

Group	Value	95% CI
Dilapan-S	9	8 – 10
Cook Catheter	8	5 – 9

Mode of Delivery: Vaginal Delivery, Cesarean Delivery Secondary · Assessed at the time of delivery, within 1 week

Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery

Vaginal delivery

Group	Value	95% CI
Dilapan-S	30
Cook Catheter	30

Cesarean delivery

Group	Value	95% CI
Dilapan-S	10
Cook Catheter	10

Time on Labor and Delivery Secondary · Assessed at the time of delivery, within 1 week

Time from admission on labor and delivery until delivery. Measured in hours.

Group	Value	95% CI
Dilapan-S	20.1	13.9 – 26.2
Cook Catheter	17.0	11.7 – 28.4

Maternal Length of Stay Secondary · Assessed at end of study period (week 4)

Admission Date/Time to Discharge Date/Time

Group	Value	95% CI
Dilapan-S	3.2	2.7 – 4.7
Cook Catheter	2.9	2.7 – 3.9

Cervical Ripening Success Score: No Failure, Failure Secondary · Assessed at the time of device removal, within 24 hours

Failure defined by: inability to place intervention agent or need for further cervical ripening after removal

No failure

Group	Value	95% CI
Dilapan-S	33
Cook Catheter	25

Failure

Group	Value	95% CI
Dilapan-S	7
Cook Catheter	15

Composite Maternal Morbidity: Morbidity, no Morbidity Secondary · Assessed at end of study period (week 4)

Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death

Morbidity

Group	Value	95% CI
Dilapan-S	8
Cook Catheter	8

No Morbidity

Group	Value	95% CI
Dilapan-S	32
Cook Catheter	32

Composite Neonatal Morbidity: Morbidity, no Morbidity Secondary · Assessed at end of study period (week 4)

Morbidity defined as any one of the following: culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia

Morbidity

Group	Value	95% CI
Dilapan-S	1
Cook Catheter	0

No morbidity

Group	Value	95% CI
Dilapan-S	39
Cook Catheter	40

Sponsor's own description

The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.

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:

Other trials of Dilapan-S

Trials testing the same drug.

NCT05099991 — Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion · NA · completed
NCT04451109 — Dilapan-S®: A Multicenter US E-registry · active not recruiting
NCT03710239 — OPIOID Study - Pain With Osmotic Dilators · NA · completed
NCT03001661 — An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt · Phase 3 · completed

Other recruiting trials for Induced; Birth

Currently open trials in the same condition.

NCT05719467 — SAINT: Safe Induction of Labor Trial · Phase 3 · recruiting

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05062343 (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 Brigham and Women's Hospital
Last refreshed: 27 October 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/NCT05062343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing