Sublingual Misoprostol and Tranexamic Acid in Pregnant Wo... | NCT03774524

Studies
Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

NCT03774524

Sponsor

Aswan University Hospital

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

150Estimated

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

Mar 1, 2021Estimated

First Submitted Date

Dec 12, 2018

First Submission Date that Met QC Criteria

Dec 12, 2018

First Posted Date

Dec 13, 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 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hany farouk, Principal Investigator, Aswan University HospitalPrincipal Investigator

Lead Sponsor

Aswan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.

Detailed Description

Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy.

With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy

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

150Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	400 μg of sublingual 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:

women with a multiple term pregnancy undergoing elective cesarean section

Exclusion Criteria:

single gestation
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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with a multiple term pregnancy undergoing elective cesarean section

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	002	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