Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

NCT ID: NCT01733329

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Misoprostol

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.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.

Folic Acid

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.

Group Type: PLACEBO_COMPARATOR

Folic Acid

Intervention Type: DRUG

At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Interventions

Misoprostol

At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.

Intervention Type: DRUG

Folic Acid

At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Intervention Type: DRUG

Other Intervention Names

Cytotec; Placebo

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

Flavio Hernández Castro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, Mexico

Countries

Mexico

References

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. doi: 10.1016/j.ajog.2004.12.033.

Reference Type: BACKGROUND

PMID: 15902121 (View on PubMed)

Hernandez-Castro F, Lopez-Serna N, Trevino-Salinas EM, Soria-Lopez JA, Sordia-Hernandez LH, Cardenas-Estrada E. Randomized double-blind placebo-controlled trial of buccal misoprostol to reduce the need for additional uterotonic drugs during cesarean delivery. Int J Gynaecol Obstet. 2016 Feb;132(2):184-7. doi: 10.1016/j.ijgo.2015.06.060. Epub 2015 Oct 23.

Reference Type: DERIVED

PMID: 26534874 (View on PubMed)

Other Identifiers

GI07-011

Identifier Type: -

Identifier Source: org_study_id