Nulliparous women with induction of labor at term and a singleton fetus in vertex position
Conditions
Interventions
Product Name: Sodium Hydrogen Carbonate
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Buscopan
Pharmaceutical For
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be between 18 and 50 years of age at the time of signing the informed consent. 2. Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation 3. Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made 4. Participants carrying a fetus in vertex position 5. 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Multiple gestation 2. Elective cesarean section 3. Spontaneous start of labor 4. Known maternal intestinal stenosis, ileus or megacolon 5. Persisting maternal tachycardia (heart rate > 130 beats per minute) >30 minutes continuously. 6. Known maternal myasthenia gravis 7. Persisting fetal tachycardia (fetal heart rate baseline > 170 beats per minute) >30 minutes continuously. 8. Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride) 9. Women with heart disease who are under surveillance with heart rate monitoring during labor 10. Known fetal heart disease or known fetal malformations in the gastrointestinal system 11. Untreated maternal glaucoma 12. Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia 13. Maternal moderate/severe kidney failure (stage III-V: glomerulus filtration rate 90umol/L) 15. Maternal elevated Alanine Aminotransferase (ALAT) >50 U/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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;Secondary Objective: •To assess the efficacy of bicarbonate tablets compared to placebo tablets, intravenous butylscopolamine bromide compared to intravenous placebo and combined bicarbonate tablets and intravenous butylscopolamine bromide compared to placebo tablets and intravenous placebo on - shortening duration of labor - rates of operative vaginal delivery - rates of cesarean section - postpartum hemorrhage - use of oxytocin - urinary retention - anal sphincter injury - Apgar score - pH in umbilical vessels - transfer to NICU - birth experience;Primary end point(s): •Spontaneous vaginal delivery (no cesarean section, no forceps delivery, no vacuum delivery) vs. operative delivery (dichotomous variable);Timepoint(s) of evaluation of this end point: At delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration from when the participant was given IMP to delivery (time-to-event variable) • Duration from when the participant was given IMP to 10 cm dilatation (time–to-event variable) • Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm (continuous variable) • Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery (time-to-event variable) • Vaginal delivery vs cesarean delivery (dichotomous variable) • Mode of delivery (spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery) (nominal variable) • Amount of oxytocin administered, measured 1. As total time with treatment (continuous variable) 2. As International Units (IU). The midwife measures mL of oxytocin solution given during labor. IU are calculated based on standardized concentration of the infusion solution [10 IU oxytocin in 1000 mL NaCl solution] (continuous variable). • Change in pain score from baseline to 30 minutes after each IMP administration using a Visual Analogue Scale (continuous variable) • Postpartum hemorrhage (continuous variable) • Postpartum hemorrhage > 500 mL) (dichotomous variable) • Postpartum hemorrhage > 1000 mL) (dichotomous variable) • Postpartum hemorrhage > 1500 mL) (dichotomous variable) • Urinary retention, defined as need for urinary catheter before the participant leaves the delivery ward (dichotomous variable) • Urinary retention, defined as need for urinary catheter before the participant leaves the maternity ward (dichotomous variable) • Urinary retention, defined as need for urinary catheter after the participant leaves the maternity ward (dichotomous variable) • Anal sphincter injury, defined as obstetric anal sphincter injury grade 3 or 4 (dichotomous variable) • CTG or STAN effects after administration of IMP measured as changes in o Fetal heart rate variability o Basal heart rate o Desceleration o Short term variability • Amn | — |
Countries
Norway
Contacts
Public ContactDepartment of Obstetrics
Oslo University Hospital
Outcome results
None listed