EUCTR2019-002032-84-CZ
Active, not recruiting
Phase 1
Evaluating the Use of a Progesterone Receptor Modulator for Cervical Ripening at Full Term Pregnancy – a Randomized, Double-blind , placebo controlled Study (LUCYNA) - LUCYNA
Disphar International B.V0 sites150 target enrollmentJune 11, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Disphar International B.V
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 – 40 years
- •Pregnancy \= 40 Weeks \+ 5 days
- •Bishop Score \= 5
- •Intact membranes
- •BMI \= 30 before pregnancy
- •Primiparous women
- •Singleton pregnancy
- •Physiological pregnancy (no risk factors, no abnormalities in clinical and laboratory examinations during pregnancy)
- •Agreeing to participate in the study
- •Signed written informed consent for study participation
Exclusion Criteria
- •any contraindication to vaginal delivery
- •previous late abortion (\= 12 week of pregnancy)
- •uterine scar
- •cephalopelvic disproportion
- •placenta praevia
- •fetal malpresentation
- •chorioamnionitis
- •fetal congenital abnormalities
- •participation in a clinical trial with investigational drugs within the last 3 months before the enrolment or during the present trial period.
- •significant maternal cardiac, renal or hepatic disease or any condition,which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study
Outcomes
Primary Outcomes
Not specified
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