A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy. At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH \< 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery. Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted. Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events. The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Participant must be between 18 and 50 years of age at the time of signing the informed consent.

• Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation

• Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made

• Participants carrying a fetus in vertex position

• Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Locations
Other Locations
Norway
Akershus University Hospital
RECRUITING
Lørenskog
Oslo University Hospital Rikshospitalet
RECRUITING
Oslo
Oslo University Hospital Ullevål
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
The University Hospital of North Norway
RECRUITING
Tromsø
Contact Information
Primary
Trond M Michelsen, MD PhD
trmi1@ous-hf.no
+4723070000
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 3000
Treatments
Active_comparator: Buscopan and bicarbonate
Active_comparator: Buscopan and placebo
Active_comparator: Placebo and bicarbonate
Placebo_comparator: Placebo and placebo
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov