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Use of preoperative sodium bicarbonate among women with obstructed labor (SoBicOL- II)

Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202405917242393
Enrollment
280
Registered
2024-05-24
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Sponsors

Busitema University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: We will include patients with obstructed labour carrying singleton, term pregnancies (=37 weeks of gestation) in cephalic presentation.

Exclusion criteria

Exclusion criteria: We will exclude patients with other obstetric emergencies such as antepartum haemorrhage, preeclampsia and eclampsia (defined as elevated blood pressure of at least 140/90 mm Hg, urine protein of at least 2+, any of the danger signs and fits), premature rupture of membranes and intrauterine fetal death. Patients with comorbidities such as diabetes mellitus, sickle cell disease, renal disease, liver disease and heart disease. We will also exclude those patients with hypokalaemia (148 mmol/L) and alkalosis (bicarbonate >22 mmol/L) because they are more likely to develop adverse drug reactions

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the mean change in maternal pH from baseline in each group. In umbilical blood it will be the mean pH in each arm of the study

Secondary

MeasureTime frame
The secondary outcomes will include mean lactate in maternal and umbilical blood, early neonatal death, safety (side effects) of sodium bicarbonate, primary postpartum hemorrhage, sepsis and death. Furthermore, the plasma concentrations of bicarbonate levels will be measured as well to accurately estimate the required dose.

Countries

Uganda

Contacts

Public ContactRitah Nantale

Research Manager

ritahclaire24@gmail.com256702035356

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026