Buccal Misoprostol and Intravenous Tranexamic Acid During... | NCT03777696

Studies
Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

NCT03777696

Sponsor

hany farouk

Status

Unknown status

Last Update Posted

Feb 18, 2019Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Cesarean Section Complications

Interventions

Misoprostol
TA
placebo to misoprostol
placebo to TA

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jan 31, 2021Estimated

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hany farouk, Principal Investigator, Aswan University HospitalSponsor-Investigator

Lead Sponsor

hany faroukOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section

Detailed Description

The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much.T he buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol with TA	Active Comparator	400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout	Drug: Misoprostol Drug: TA
Misoprostol with placebo to TA	Active Comparator	400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout	Drug: Misoprostol Drug: placebo to TA
placebo to Misoprostol and TA	Placebo Comparator	placebo to misoprostol plus placebo to tranexamic acid	Drug: TA Drug: placebo to misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	400 μg of buccal misoprostol	Misoprostol with TA Misoprostol with placebo to TA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation

Secondary Outcomes

Measure	Description	Time Frame
amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	6 hours post operative
number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor

Exclusion Criteria:

multiple gestations
placenta praevia and placental abruption
undergoing cesarean section with general anesthesia
women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
allergy to tranexamic acid or misoprostol
refuse to consent
elective cesarean section

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hany f sallam, md	Contact	01022336052		hany.farouk@aswu.edu.eg

Overall Officials

Name	Affiliation	Role
hany f sallam, md	Aswan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aswan University	Recruiting	Aswān		81528	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided