Evaluating the effect of a drug that at full-term preganacy, softens the neck of the womb ready for delivery

Phase 1

• Conditions: Full-term pregnancy women at week 40 + 5 of gestation with intact membranes, the first delivery, singleton physiological pregnancy; MedDRA version: 21.1Level: LLTClassification code 10036880Term: Prolonged pregnancy, with deliverySystem Organ Class: 100000004868; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2019-002032-84-CZ
• Lead Sponsor: Disphar International B.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 150

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified