Ideal Time of Oxytocin Infusion During Cesarean Section (I-TOPICS)

Loyola University

Status and phase: Terminated; Phase 4

Conditions: Bleed Pregnancy; Cesarean Section Complications; Pregnancy Related; Blood Loss, Surgical; Postpartum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03246919

209632

Details and patient eligibility

About

This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

Full description

Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.

This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women undergoing cesarean section at Loyola Hospital
• Women who read and speak the English and/or Spanish language
• Women age 18 or older

Exclusion criteria

• Women who deliver vaginally
• Gestation under 37 weeks and 0 days
• Women with coagulopathies
• Multiple gestation pregnancies
• Antepartum hemorrhage for example abruption
• Placental abnormalities for example previa, accreta

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Control (Group A)

Placebo Comparator group

Description:

One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.

Treatment:

Drug: Placebo

Intervention (Group B)

Active Comparator group

Description:

One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.

Treatment:

Drug: Oxytocin