Status:
COMPLETED
Outpatient Labor Induction Using Oral Misoprostol in Norway
Lead Sponsor:
Oslo Metropolitan University
Collaborating Sponsors:
Oslo University Hospital
Vestre Viken Hospital Trust
Conditions:
Induced; Birth
Labor, Induced
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief Summary
The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. In Denmark, a...
Detailed Description
The labor induction rate in Norway has increased from 10,5 % in 2000 to 26,1 % in 2019. This represents an important shift in the obstetric care, making labor induction one of the most common obstetri...
Eligibility Criteria
Inclusion
- Healthy nulliparous women
- A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
- Normal pregnancy
- The woman can read and communicate in Norwegian
- No cognitive barriers
- BMI 15,5-39,9
- Reside within one hour from the hospital
- Indication for labor induction is post term pregnancy, uncomplicated pre labor rupture of membranes, maternal wish or other indications determined as low-risk by the attending obstetrician
Exclusion
- Known uterine abnormality or previous uterine surgery
- Major maternal medical illness requiring monitoring of mother or fetus in early labor
- Maternal infection
- Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
- Active vaginal bleeding characterized as more than bloody show
- Smoking
- Non-reassuring cardiotocography or reduced fetal movement
- Fetal growth EFW \< 10th percentile or \>90th percentile
- Poly- or oligohydramnios
- Known abnormalities in the placenta or umbilical cord
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04746248
Start Date
March 25 2021
End Date
December 31 2022
Last Update
March 24 2023
Active Locations (2)
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1
Vestre Viken Health Trust, Drammen Hospital
Drammen, Norway
2
Oslo University Hospital
Oslo, Norway