Trial Outcomes & Findings for Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²) (NCT NCT02649920)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

24 hours

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cervical Ripening Balloon Prospective Cervical ripening balloon	Dinoprostone Retrospective Dinoprostone
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Ripening Balloon n=2 Participants Prospective Cervical ripening balloon	Dinoprostone Retrospective Dinoprostone	Total n=2 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 2.12 • n=5 Participants	—	26.5 years STANDARD_DEVIATION 2.12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Cervical Ripening Balloon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dinoprostone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guillaume DUCARME

Centre Hospitalier Départemental Vendée

Phone: 02 51 44 61 61

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place