DRUG
carbetocin
Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery
Status
Completed
Phase
Not applicable
Enrollment
360
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
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.
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.
Timeline
From registration to results.
First posted
Oct 17, 2018
Study start
Dec 1, 2018
Primary completion
May 31, 2020
Study completion
Jul 1, 2020
Results posted
Not reported
Registry updated
Aug 5, 2020
Outcomes
What the study measures.
Primary outcomes
difference in the mean blood loss at 4 h postpartum between the three groups
Time frame · 4 hours post delivery
measure blood loss by direct and gravimetric methods
Secondary outcomes
difference in hemoglobin level
Time frame · 24 hours postdelivery
hemoglobin level pre delivery and 24 hours post delivery
the need for additional uterotonics
Time frame · ist 24 hours postoperative
the need of additional oxytocin or misoprostol
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 40 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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.
Study locations
2 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Aswan University
Aswān, Egypt
AswanUH
Aswān, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
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Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
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Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
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Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
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Not applicable
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Related PeptideStat pages
Put the record in context.
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