Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Study Overview
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Brief Summary
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Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage. Design: randomized, double-blinded, placebo-controlled trial.

Detailed Description
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Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Official Title
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Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Folic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below: Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula). Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm) Twin or Multiple pregnancy. Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour). Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section. Intravenous oxytocin therapy for at least 4 hours before cesarean section. Multiparous women (≥ 3 prior abdominal or vaginal deliveries ) Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (> 160 beats per minute), maternal tachycardia (>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid. Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound. Exclusion Criteria: Misoprostol incorrect administration Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use. Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony. | Drug: Misoprostol<br>* At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.<br>* Other names: Cytotec;|
| Placebo Comparator: Folic Acid<br>women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony. | Drug: Folic Acid<br>* At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Additional Uterotonic Medications | The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Atony | Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, boggy uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction. | 24 hours | 
| Postpartum Hemorrhage | Defined as: Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion | 24 HOURS | 
| Blood Loss |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buccal Misoprostol, Uterine Atony, Postpartum Hemorrhage