Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Postpartum Hemorrhage	Drug: Misoprostol; Drug: Folic Acid	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	123 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
Study Start Date :	February 2008
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	Drug: Misoprostol; At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.; Other Name: Cytotec
Placebo Comparator: 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.	Drug: Folic Acid; At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.; Other Name: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Need for Additional Uterotonic Medications [ Time Frame: 24 hours ]
   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.

Secondary Outcome Measures :

1. Uterine Atony [ Time Frame: 24 hours ]
   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.
2. Postpartum Hemorrhage [ Time Frame: 24 HOURS ]

   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

3. Blood Loss [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 64460

Sponsors and Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hernández-Castro F, López-Serna N, Treviño-Salinas EM, Soria-López JA, Sordia-Hernández LH, Cárdenas-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.

Responsible Party:	Flavio Hernández Castro, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:	NCT01733329 History of Changes
Other Study ID Numbers:	GI07-011
First Posted:	November 27, 2012
Results First Posted:	March 31, 2014
Last Update Posted:	March 31, 2014
Last Verified:	February 2014

Keywords provided by Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez:

Buccal Misoprostol; Uterine Atony; Postpartum Hemorrhage

Additional relevant MeSH terms:

Hemorrhage; Postpartum Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Misoprostol; Folic Acid; Vitamin B Complex; Abortifacient Agents, Nonsteroidal	Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Oxytocics; Hematinics; Vitamins; Micronutrients; Growth Substances