Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
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ClinicalTrials.gov Identifier: NCT00545194 |
Recruitment Status :
Completed
First Posted : October 17, 2007
Last Update Posted : October 17, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Ripening Labor, Induced | Drug: Prostaglandin E2 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 446 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy |
Study Start Date : | January 2002 |
Actual Study Completion Date : | October 2004 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
sustained release preparation of prostaglandin E2
|
Drug: Prostaglandin E2 |
Active Comparator: B
short-acting (instant-released) preparation of prostaglandin E2
|
Drug: Prostaglandin E2 |
- Percentage of vaginal deliveries within the 48 hours after cervical ripening [ Time Frame: 48 hours ]
- Proportion of total vaginal deliveries [ Time Frame: 48 hours ]
- Vaginal deliveries at 12 hours, 24 hours and 36 hours [ Time Frame: 48 hours ]
- Number of hyperkinesia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
- Number of hypertonia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
- Apgar score at 5 min less or equal 7 [ Time Frame: 48 hours ]
- Apgar score at 10 min less or equal 7 [ Time Frame: 48 hours ]
- Arterial pH less or equal 7.20 [ Time Frame: 48 hours ]
- Arterial base excess more than 12 [ Time Frame: 48 hours ]
- Number of maternal post-partum haemorrhage [ Time Frame: 48 hours ]
- Time to reach 3cm cervical dilatation [ Time Frame: 48 hours ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- singleton pregnancy
- cephalic presentation
- gestation of more than 37 Weeks confirmed by ultrasound
- Bishop score less than 7
- Informed consent
Exclusion Criteria:
- previous cesarean section (scarred uterus)
- polyhydramnios
- multiple pregnancy
- fetal malformation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545194
France | |
Olympe de Gouges Women Health Centre, Bretonneau University Hospital | |
Tours, France, 37044 |
Principal Investigator: | Franck Perrotin, MD-PhD | Tours Universiity Hospital |
ClinicalTrials.gov Identifier: | NCT00545194 |
Other Study ID Numbers: |
PROPESS Study |
First Posted: | October 17, 2007 Key Record Dates |
Last Update Posted: | October 17, 2007 |
Last Verified: | October 2007 |
Prostaglandin E2 Intravaginal gel Bishop score |
Induction of labor randomized trial Vaginal insert |
Dinoprostone Oxytocics Reproductive Control Agents Physiological Effects of Drugs |