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RecruitingPhase 3NCT06579690

Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor

Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial

Sponsor

Busitema University

Enrollment

472 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Obstructed Labor

Summary

The goal of this clinical trial is to determine a universal safe and effective dose of sodium bicarbonate for use among women with Obstructed labour to treat acidosis. It will also learn about the safety of sodium bicarbonate drug among women with Obstructed labour. Researchers will compare sodium bicarbonate drug to normal saline (a look-alike solution) to see if sodium bicarbonate works to treat acidosis. Participants will receive sodium bicarbonate solution or a placebo up to two doses, four hours apart.

Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 49 Years

Inclusion Criteria4

  • Patients with obstructed labour
  • Must be a singleton pregnancy
  • Must be a term pregnancy (≥37 weeks of gestation)
  • Must be in cephalic presentation.

Exclusion Criteria3

  • 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.
  • Patients with hypokalaemia (148 mmol/L) and alkalosis (bicarbonate >22 mmol/L) because they are more likely to develop adverse drug reactions

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Interventions

DRUG8.4% sodium bicarbonate solution

Sodium bicarbonate infusion 8.4% solution The study drug will be contained in identical 25 mL glass vials (Neon Laboratories Ltd, Mumbai, India), administered intravenously as a single bolus dose.

OTHER0.9% Normal Saline

The comparision group will receive 50 mls of 0.9% Normal Saline

Locations(1)

Mbale Regional Referral Hospital

Mbale, Uganda

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NCT06579690