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

NCT ID: NCT03708497

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-07-01

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.

Detailed Description

All women admitted to the reception unit for vaginal delivery were invited to participate in the study. The investigators included women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation. The participated women have entered the screening phase of the study. This phase included history taking (age, parity, and gestational age) with measurement of weight, temperature, and initial hemoglobin level. The investigators excluded women with 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. 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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

carbetocin

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

Group Type: ACTIVE_COMPARATOR

carbetocin

Intervention Type: DRUG

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

Tranexamic acid plus misoprostol

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.

Group Type: EXPERIMENTAL

Tranexamic acid plus misoprostol

Intervention Type: 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.

misoprostol

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.

Group Type: ACTIVE_COMPARATOR

misoprostol

Intervention Type: 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.

Interventions

carbetocin

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

Intervention Type: DRUG

Tranexamic acid plus misoprostol

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.

Intervention Type: DRUG

misoprostol

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.

Intervention Type: DRUG

Other Intervention Names

Active Comparator; active comparator; active comparator

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

AswanUH

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/293/9/18

Identifier Type: -

Identifier Source: org_study_id