Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery

NCT03708497 | Completed

• 1 other identifier: aswu/293/9/18
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

Excessive bleeding at or after childbirth accounts for about half of all the post-partum maternal deaths in developing countries and is the single most important cause of maternal mortality worldwide. Post-partum hemorrhage (PPH) is the major contributor to maternal mortality worldwide representing at least 25% of the maternal deaths annually. Prevention of PPH has become a global aim to reduce maternal mortality. Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 hours of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Misoprostol is effective when given orally, buccal, sublingually, vaginally, or rectally, so it might be used by traditional birth attendants, or self-administered, in cases of home-births occurred without the attendance of health personnel or where women are at most risk for occurrence of severe PPH. So, the current study aims to evaluate the effect of prophylactic oral TA plus buccal misoprostol in the prevention of primary PPH after routine active management of the third stage of labor in women at low risk for uterine atony in comparison with carbetocin and buccal misoprostol alone.

Conditions

Postpartum Hemorrhage

Keywords

carbetocin; tranexamic acid; postpartum hemorrhage; buccal misoprostol

Outcome Measures

Primary Outcomes (1)

• difference in the mean blood loss at 4 h postpartum between the three groups

  measure blood loss by direct and gravimetric methods

  4 hours post delivery

Secondary Outcomes (2)

• difference in hemoglobin level

  24 hours postdelivery

• the need for additional uterotonics

  ist 24 hours postoperative

Study Arms (3)

carbetocin

ACTIVE COMPARATOR

Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute

Drug: carbetocin

Tranexamic acid plus misoprostol

EXPERIMENTAL

1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

Drug: Tranexamic acid plus misoprostol

misoprostol

ACTIVE COMPARATOR

600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

Drug: misoprostol

Interventions

carbetocin DRUG

Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute

Also known as: Active Comparator

carbetocin

Tranexamic acid plus misoprostol DRUG

1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

Also known as: active comparator

Tranexamic acid plus misoprostol

misoprostol DRUG

600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

Also known as: active comparator

misoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: All women admitted to the reception unit for vaginal delivery were invited to participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All women admitted to the reception unit for vaginal delivery
• women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation.

You may not qualify if:

• medical disorders such as cardiac, hepatic, renal, neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational hypertension, and pre-eclampsia.
• Women at risk for PPH as grand multipara (parity \>5), multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and obstructed labor were also excluded.-
• Moreover, we excluded women with a scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to TA.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (2)

Aswan University

Aswān, 81528, Egypt

Location

AswanUH

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Tranexamic Acid; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: women were allocated to one of the three study groups: group I (carbetocin group) received 100 mc carbetocin IV after delivery of the baby, group II (misoprostol group) received 600 mg buccal misoprostol after delivery of the baby, and group III (TA plus misoprostol group) received 1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 17, 2018
• Study Start: December 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: July 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)