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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buscopan and bicarbonate | Active Comparator |
| |
| Buscopan and placebo | Active Comparator |
| |
| Placebo and bicarbonate | Active Comparator |
| |
| Placebo and placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buscopan 20 MG/ML Injectable Solution | Drug | 1 mL intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous vs operative birth | Number of participants with operative birth as compared to spontaneous birth | Through study completion, an average of one week |
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Inclusion Criteria:
Exclusion Criteria:
Only pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trond M Michelsen, MD PhD | Contact | +4723070000 | trmi1@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Trond M Michelsen, MD PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Recruiting | Lørenskog | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40032397 | Derived | Sorbye IK, Gunnes N, Solhoff AV, Haavaldsen C, Kessler J, Kjollesdal AM, Jacobsen AF, Magnussen EB, Pettersen ATR, Sande RK, Sjoborg KD, Ween-Velken ME, Leeves LT, Michelsen TM; SAINT Consortium. Multicentre double-blind randomised placebo-controlled four-arm trial to assess the effect of oral sodium bicarbonate and intravenous hyoscine butylbromide on spontaneous delivery after induction of labour in nulliparous women: protocol for the Safe Induction of Labour Trial (SAINT). BMJ Open. 2025 Mar 3;15(3):e093992. doi: 10.1136/bmjopen-2024-093992. |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D017693 | Sodium Bicarbonate |
| D013607 | Tablets |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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| Sodium bicarbonate | Drug | 4 g orally |
|
| Placebo | Drug | 4g orally |
|
|
| Nacl 0.9% | Drug | 1 mL intravenously |
|
|
| Oslo University Hospital Rikshospitalet | Recruiting | Oslo | 0424 | Norway |
|
| Oslo University Hospital Ullevål | Recruiting | Oslo | Norway |
|
| Stavanger University Hospital | Recruiting | Stavanger | Norway |
|
| The University Hospital of North Norway | Recruiting | Tromsø | Norway |
|
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |