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Trial record 10 of 618 for:    Hemorrhage AND postpartum

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT01733329
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : March 31, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Postpartum Hemorrhage
Interventions Drug: Misoprostol
Drug: Folic Acid
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) 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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

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Period Title: Overall Study
Started 62 61
Completed 60 60
Not Completed 2 1
Reason Not Completed
Protocol Violation             1             1
Uterine artery injury             1             0
Arm/Group Title Misoprostol Folic Acid Total
Hide Arm/Group Description

women with risk factors for uterine atony who underwent cesarean delivery 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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery 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.

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Total of all reporting groups
Overall Number of Baseline Participants 62 61 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 61 participants 123 participants
24.05  (5.32) 25.18  (6.29) 24.62  (5.83)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 61 participants 123 participants
<=18 years
7
  11.3%
4
   6.6%
11
   8.9%
Between 18 and 65 years
55
  88.7%
57
  93.4%
112
  91.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 61 participants 123 participants
Female
62
 100.0%
61
 100.0%
123
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 62 participants 61 participants 123 participants
62 61 123
1.Primary Outcome
Title Need for Additional Uterotonic Medications
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description:

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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

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Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
10 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol, Folic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Uterine Atony
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description:

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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

Placebo

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of participants
8.3 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol, Folic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Postpartum Hemorrhage
Hide Description

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

Time Frame 24 HOURS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description:

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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

Placebo

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of patients
6.6 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol, Folic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Blood Loss
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description:

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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

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Overall Number of Participants Analyzed 60 60
Median (Standard Deviation)
Unit of Measure: mL
470  (149.91) 653.33  (342.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol, Folic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Misoprostol Folic Acid
Hide Arm/Group Description

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.

Misoprostol

women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (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.

Placebo

All-Cause Mortality
Misoprostol Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Misoprostol Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Misoprostol Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
  1. Technical problems with blood loss measurement leading to blood transfusion before receiving hematocrit result.
  2. Small number of patients fulfill inclusion criteria.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Flavio Hernández Castro
Organization: Hospital Universitario José Eleuterio González, Universidad Autónoma de Nuevo León
Phone: 8112776459
Responsible Party: Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01733329     History of Changes
Other Study ID Numbers: GI07-011
First Submitted: November 16, 2012
First Posted: November 27, 2012
Results First Submitted: December 14, 2013
Results First Posted: March 31, 2014
Last Update Posted: October 11, 2018