A Phase 3 interventional study of Buscopan 20 MG/ML Injectable Solution and Sodium bicarbonate in Labor Complication, Induced; Birth and Pregnancy Related, sponsored by Oslo University Hospital. Recruiting at 5 sites in Norway. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Oslo University Hospital · Phase 3, Interventional, and Treatment
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.
89 studies on the registry are indexed under Obstetric Labor Complications; 25 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 150 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
Drug: Buscopan 20 MG/ML Injectable Solution · Drug: Sodium bicarbonate
Drug: Buscopan 20 MG/ML Injectable Solution · Drug: Placebo
Drug: Sodium bicarbonate · Drug: Nacl 0.9%
Drug: Placebo · Drug: Nacl 0.9%
1 mL intravenously
4 g orally
4g orally
Also known as: Oral Tab
1 mL intravenously
Also known as: Intravenous placebo
Spontaneous vs operative birth
Number of participants with operative birth as compared to spontaneous birth
Time frame: Through study completion, an average of one week
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Obstetric Labor Complications→
Oslo University Hospital