Safe dose of oxytocin to control excessive bleeding from uterus during cesarean section in patients with body weight above normal

Active, not recruiting

• Conditions: Other complications of obstetric surgery and procedures,

• Registration Number: CTRI/2022/05/042469
• Lead Sponsor: UCMS and GTBH

Brief Summary

Introduction: Postpartum hemorrhage (PPH) is a major cause of maternal morbidity and mortality.The commonest cause of PPH is uterine atony. We plan to evaluate the minimum effective dose of oxytocin infusion for adequate uterine tone during cesarean section in non-laboring obese patients, and compare it with a control group of non-obese patients. Herein, the ED90 dose will be taken to represent the “minimum effective doseâ€.

Non-laboring patients scheduled for caesarean section under spinal block will be included. Those with body mass index ≥30 kg/m2 will be included as “obese†and those with <30 kg/m2 as “non-obese†cohort.

The anaesthetic management for both the groups will be standardized as per routine practice. Oxytocin infusion will be initiated upon clamping of the umbilical cord, in the first patient of each group (Obese and non-obese).

The dose of the infusion will be 13 IU/h (i.e., 0.22 IU/min) for the first patient in both cohorts (obese vs. non-obese controls). The uterine tone will be assessed and graded as satisfactory or unsatisfactory by the obstetrician, 4 minutes after the initiation of the oxytocin infusion. If uterine tone is deemed satisfactory with designated dose of oxytocin, the dose will be categorized as a “successâ€, and the infusion will be continued till end of surgery at same rate. In case of an unsatisfactory uterine tone, the dose will be considered as a “failure†and the infusion rate doubled in the particular patient (not greater than 36 IU/h). If uterine tone does not improve after another 3- to 6-minute period, an additional uterotonic agent as well as uterine massage will be administered.

The dose in subsequent cases for both cohorts will be decided by the response to oxytocin in previous patient of particular cohort. After a “failed†dose of oxytocin, the next patient of the cohort will receive an infusion rate increased by 2 IU/h. In case of a “successful†dose, the next subject’s infusion rate will be determined via a biased allocation method with 90% chance to maintain the same infusion rate and a 10% chance to decrease the infusion rate by 2 IU/h. This method of biased allocation will be determined by drawing black and white marbles (ratio 1:9) out of an opaque bag. The allocation assignments will be concealed in sequentially numbered opaque envelopes by an investigator not involved in the clinical care of the patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• All non-laboring parturient >18 years age will be enrolled.
• The two arms will include obese (body mass index ≥30 kg/m2) or non-obese pregnant patients (body mass index < 30 kg/m2) posted for cesarean section under spinal anesthesia.

Exclusion Criteria

Exclusion criteria shall be patient refusal, presence of labor (defined as cervical dilatation of 3 cm or more), use of oxytocin in the preoperative period, history of PPH or more than one previous uterine surgery as well as bleeding disorders, presence of abnormal placentation and uterine fibroid, contraindications to spinal block, such as hemodynamic instability, infection at the injection site, and coagulopathy (thrombocytopenia with platelet count<100,000/mm3 or INR>1.5).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The calculated ED90 of prophylactic oxytocin infusion in both cohorts	The status of uterine tone assessed by the operating obstetrician ( satisfactory or unsatisfactory) at 4-minute post oxytocin intiation.

Secondary Outcome Measures

Name	Time	Method
The requirement of additional uterotonic drugs.	From cord clamping to end of surgery.

Trial Locations

Locations (1)

University College of Medical Sciences and GTB Hospital; 🇮🇳 East, DELHI, India

University College of Medical Sciences and GTB Hospital

🇮🇳East, DELHI, India

Dr Asha Tyagi

Principal investigator

011-22692415

drashatyagi@gmail.com