Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733329
• Other study ID #: GI07-011
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: December 2013

Study information

• Verified date: October 2018
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

1. Fetal macrosomia (estimated fetal weight = 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).

2. Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)

3. Twin or Multiple pregnancy.

4. Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation = 10 cm/hour).

5. Magnesium sulphate or any other tocolytic agent therapy for = 8 hours before cesarean section.

6. Intravenous oxytocin therapy for at least 4 hours before cesarean section.

7. Multiparous women (= 3 prior abdominal or vaginal deliveries )

8. 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.

9. Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion Criteria:

1. Misoprostol incorrect administration

2. Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.

3. Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
• Folic Acid
At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. José Eleuterio González	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Hamm J, Russell Z, Botha T, Carlan SJ, Richichi K. Buccal misoprostol to prevent hemorrhage at cesarean delivery: a randomized study. Am J Obstet Gynecol. 2005 May;192(5):1404-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood Loss		24 hours