Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579690
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda A Phase III Randomized Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoBicOL-II
Brief 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
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
Detailed Description:
Oral bicarbonate is a safe cheap and effective acid buffer widely used in sports to improve performance because of its ability to prevent and reverse the effects of metabolic acidosis Clinically it is used in intensive care units to treat patients with overwhelming infections or poisoning In low resource settings obstructed labor OL is a major problem that accounts for 22 of maternal deaths The fetal harm of OL comes from intrapartum asphyxia characterized by accumulation of hydrogen ions that cross the placental barrier to cause fetal acidosis Acidosis causes failure of basic cellular functions resulting into cell death In a recent Randomised Clinical Trial the investigators found that 61 of 477 women with OL were acidotic lactate 48 mmolL with a median capillary blood lactate level of 69 34-13 mmolL
The investigators propose an early phase III placebo-controlled dose-ranging trial to determine the efficacy and safety of a pre-operative infusion of sodium bicarbonate in women with obstructed labour OL In a ratio of 111 1 100 mls 84g 150 mls 126g and 200 mls 168g of 84 sodium bicarbonate solution or placebo 50 mls of Normal Saline 09 The primary outcome will be mean change in acidosis pH and lactate levels from baseline The secondary outcomes will be neonatal death safety of sodium bicarbonate pharmacokinetics of sodium bicarbonate in pregnant women primary postpartum haemorrhage sepsis and maternal death
The investigators propose an early phase III placebo-controlled dose-ranging trial to determine the efficacy and safety of a pre-operative infusion of sodium bicarbonate in women with obstructed labour OL In a ratio of 111 1 100 mls 84g 150 mls 126g and 200 mls 168g of 84 sodium bicarbonate solution or placebo 50 mls of Normal Saline 09 The primary outcome will be mean change in acidosis pH and lactate levels from baseline The secondary outcomes will be neonatal death safety of sodium bicarbonate pharmacokinetics of sodium bicarbonate in pregnant women primary postpartum haemorrhage sepsis and maternal death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None