Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage
This study has been completed.
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01733329
First received: November 16, 2012
Last updated: February 12, 2014
Last verified: February 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Postpartum Hemorrhage |
Drug: Misoprostol Drug: Folic Acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony |
Resource links provided by NLM:
Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:
Primary Outcome Measures:
- Need for Additional Uterotonic Medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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:
- Uterine Atony [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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.
- Postpartum Hemorrhage [ Time Frame: 24 HOURS ] [ Designated as safety issue: No ]
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
- Blood Loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 123 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Names:
|
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.
Eligibility| Genders 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:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01733329
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733329
Locations
| Mexico | |
| Hospital Universitario Dr. José Eleuterio González | |
| Monterrey, Nuevo León, Mexico, 64460 | |
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
More Information
Publications:
| 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 |
| Study First Received: | November 16, 2012 |
| Results First Received: | December 14, 2013 |
| Last Updated: | February 12, 2014 |
| Health Authority: | Mexico: Ethics Committee |
Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
|
Buccal Misoprostol Uterine Atony Postpartum Hemorrhage |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Obstetric Labor Complications Pathologic Processes Pregnancy Complications Puerperal Disorders Uterine Hemorrhage Folic Acid Misoprostol Vitamin B Complex Abortifacient Agents Abortifacient Agents, Nonsteroidal |
Anti-Ulcer Agents Gastrointestinal Agents Growth Substances Hematinics Hematologic Agents Micronutrients Oxytocics Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses Vitamins |
ClinicalTrials.gov processed this record on March 03, 2015