Trial Outcomes & Findings for Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage (NCT NCT01733329)

NCT ID: NCT01733329

Last Updated: 2018-10-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 123 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2018-10-11

Participant Flow

Participant milestones

Measure	Misoprostol 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	Folic Acid 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 Study STARTED	62	61
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Misoprostol 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	Folic Acid 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 Study Protocol Violation	1	1
Overall Study Uterine artery injury	1	0

Baseline Characteristics

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Baseline characteristics by cohort

Measure	Misoprostol n=62 Participants 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	Folic Acid n=61 Participants 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. Placebo	Total n=123 Participants Total of all reporting groups
Age, Continuous	24.05 years STANDARD_DEVIATION 5.32 • n=93 Participants	25.18 years STANDARD_DEVIATION 6.29 • n=4 Participants	24.62 years STANDARD_DEVIATION 5.83 • n=27 Participants
Age, Categorical <=18 years	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=93 Participants	57 Participants n=4 Participants	112 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	62 Participants n=93 Participants	61 Participants n=4 Participants	123 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Mexico	62 participants n=93 Participants	61 participants n=4 Participants	123 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Misoprostol n=60 Participants 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	Folic Acid n=60 Participants 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
Need for Additional Uterotonic Medications	10 percentage of participants	40 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Misoprostol n=60 Participants 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	Folic Acid n=60 Participants 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
Uterine Atony	8.3 percentage of participants	25 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Misoprostol n=60 Participants 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	Folic Acid n=60 Participants 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
Postpartum Hemorrhage	6.6 percentage of patients	20 percentage of patients

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Misoprostol n=60 Participants 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	Folic Acid n=60 Participants 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
Blood Loss	470 mL Standard Deviation 149.91	653.33 mL Standard Deviation 342.21

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Folic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Flavio Hernández Castro

Hospital Universitario José Eleuterio González, Universidad Autónoma de Nuevo León

Phone: 8112776459

Email: flaviohernandezc@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place