Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

NCT01733329 | Completed Phase 4 Results DMC

• 1 other identifier: GI07-011
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

Buccal Misoprostol; Uterine Atony; Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Uterine Atony

  24 hours

• Postpartum Hemorrhage

  24 HOURS

• Blood Loss

  24 hours

Study Arms (2)

Misoprostol

EXPERIMENTAL

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

Folic Acid

PLACEBO COMPARATOR

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

Interventions

Misoprostol DRUG

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

Also known as: Cytotec

Misoprostol

Folic Acid DRUG

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

Also known as: Placebo

Folic Acid

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (2)

• 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.

  PMID: 15902121 BACKGROUND

• 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.

  PMID: 26534874 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Interventions

Misoprostol; Folic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

1. Technical problems with blood loss measurement leading to blood transfusion before receiving hematocrit result. 2. Small number of patients fulfill inclusion criteria.

Results Point of Contact

• Title: Dr. Flavio Hernández Castro
• Organization: Hospital Universitario José Eleuterio González, Universidad Autónoma de Nuevo León

flaviohernandezc@yahoo.com

8112776459

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 27, 2012
• Study Start: February 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 11, 2018
• Results First Posted: March 31, 2014

Record last verified: 2018-10

Locations

ME (1)