Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT05719467
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SAINT: Safe Induction of Labor Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2022-12-18', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spontaneous vs operative birth', 'timeFrame': 'Through study completion, an average of one week', 'description': 'Number of participants with operative birth as compared to spontaneous birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Complication', 'Induced; Birth', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '40032397', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAt 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.\n\nGiven 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.\n\nBicarbonate 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant must be between 18 and 50 years of age at the time of signing the informed consent.\n2. Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation\n3. Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made\n4. Participants carrying a fetus in vertex position\n5. 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).\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Elective cesarean section\n3. Spontaneous start of labor\n4. Known maternal intestinal stenosis, ileus or megacolon\n5. Persisting maternal tachycardia (heart rate \\> 130 beats per minute) \\>30 minutes continuously.\n6. Known maternal myasthenia gravis\n7. Persisting fetal tachycardia (fetal heart rate baseline \\> 170 beats per minute) \\>30 minutes continuously.\n8. Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride)\n9. Women with heart disease who are under surveillance with heart rate monitoring during labor\n10. Known fetal heart disease or known fetal malformations in the gastrointestinal system\n11. Untreated maternal glaucoma\n12. Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia\n13. Maternal moderate/severe kidney failure (stage III-V: glomerulus filtration rate \\<59 ml/minute/1.73m2 )\n14. Maternal elevated serum creatinine (\\>90umol/L)\n15. Maternal elevated Alanine Aminotransferase (ALAT) \\>100 U/L. Participation can still be considered for participants with ALAT \\>100 U/L if explained by obstetric cholestasis or HELLP syndrome.'}, 'identificationModule': {'nctId': 'NCT05719467', 'acronym': 'SAINT', 'briefTitle': 'SAINT: Safe Induction of Labor Trial', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '235247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Buscopan and bicarbonate', 'interventionNames': ['Drug: Buscopan 20 MG/ML Injectable Solution', 'Drug: Sodium bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Buscopan and placebo', 'interventionNames': ['Drug: Buscopan 20 MG/ML Injectable Solution', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo and bicarbonate', 'interventionNames': ['Drug: Sodium bicarbonate', 'Drug: Nacl 0.9%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and placebo', 'interventionNames': ['Drug: Placebo', 'Drug: Nacl 0.9%']}], 'interventions': [{'name': 'Buscopan 20 MG/ML Injectable Solution', 'type': 'DRUG', 'description': '1 mL intravenously', 'armGroupLabels': ['Buscopan and bicarbonate', 'Buscopan and placebo']}, {'name': 'Sodium bicarbonate', 'type': 'DRUG', 'description': '4 g orally', 'armGroupLabels': ['Buscopan and bicarbonate', 'Placebo and bicarbonate']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Oral Tab'], 'description': '4g orally', 'armGroupLabels': ['Buscopan and placebo', 'Placebo and placebo']}, {'name': 'Nacl 0.9%', 'type': 'DRUG', 'otherNames': ['Intravenous placebo'], 'description': '1 mL intravenously', 'armGroupLabels': ['Placebo and bicarbonate', 'Placebo and placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lørenskog', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Camilla Haavaldsen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Akershus University Hospital'}, {'zip': '0424', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Trond M Michelsen, MD, PhD', 'role': 'CONTACT', 'email': 'trmi1@ous-hf.no', 'phone': '+472307000'}, {'name': 'Ingvil K Sorbye, MD, PhD', 'role': 'CONTACT', 'email': 'isorbye@ous-hf.no', 'phone': '+4723072640'}], 'facility': 'Oslo University Hospital Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Anne F Jacobsen, MD, PhD', 'role': 'CONTACT', 'email': 'uxafja@ous-hf.no'}], 'facility': 'Oslo University Hospital Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Stavanger', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ragnar K Sande, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Tromsø', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Åse T Pettersen, MD', 'role': 'CONTACT'}], 'facility': 'The University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'centralContacts': [{'name': 'Trond M Michelsen, MD PhD', 'role': 'CONTACT', 'email': 'trmi1@ous-hf.no', 'phone': '+4723070000'}], 'overallOfficials': [{'name': 'Trond M Michelsen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Senior Consultant', 'investigatorFullName': 'Trond Melbye Michelsen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}