Status:
COMPLETED
MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor
Lead Sponsor:
Karolinska Institutet
Conditions:
Induced Vaginal Delivery
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The aim of the study is to evaluate efficacy of the cervical ripening of misoprostol administration in oral tablet, Angusta® compared with the off-label solution of misoprostol (Cytotec®) for inductio...
Detailed Description
In Sweden as in most other countries, the rate of induction of labor (IOL) has steadily increased, peaking at 27% of all deliveries in 2020. Due to recently published studies showing decreased perinat...
Eligibility Criteria
Inclusion
- Singleton gestations
- Cephalic presentation
- ≥37-42+0 weeks of gestation
- Unfavorable cervix score BS \<6 in nulliparous women and \<5 in parous women
- All participating women in the studies will receive oral and written information and must give informed consent before participation
Exclusion
- Inability to understand the study information written in Swedish or English
- Previous hysterotomy (scar in the uterine myometrium)
- Non-reassuring cardiotocography (CTG) on admission (the door-test, first 20 minutes of registration of CTG).
- Hypersensitivity to the active substance
- If active labor has started
- When oxytocin infusion is already used
- Placenta previa
- Renal failure (GFR \<15 ml/min/1.73 m2).
- Any condition or circumstance due to which the investigator considers it is not in the best interest of subject to participate in the study or the inclusion of a subject risks negatively impacting the scientific or ethical integrity of the clinical trial.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2023
Estimated Enrollment :
884 Patients enrolled
Trial Details
Trial ID
NCT05424445
Start Date
January 21 2022
End Date
May 21 2023
Last Update
August 18 2023
Active Locations (1)
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1
Södersjukhuset
Stockholm, Sweden, 118 83