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Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Primary Purpose

Postpartum Hemorrhage

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Misoprostol

Placebo

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum hemorrhage, Intrapartum blood loss, Misoprostol

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Patients booked for elective cesarean section.
Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

Exclusion Criteria:

Primigravida.
Blood dyscrasias.
Large fibroids.
Multiple pregnancies.
Overdistended uterus eg. Hydramnios.
Pre-eclampsia.
Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
Previous history of PPH.
Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
Placenta previa.
Contraindication to spinal anesthesia.
Previous myomectomy.
Previous two or more C.S.

Sites / Locations

Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

sublingual misoprostol & rectal placebo

rectal & sublingual placebo

rectal misoprostol & sublingual placebo

Arm Description

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Outcomes

Primary Outcome Measures

Intraoperative Blood Loss

Secondary Outcome Measures

Need for Extra Ecbolics (Oxytocin).

APGAR Score

The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).

Time to Resume Bowel Habits

Need for Extra Analgesics

Need for Postoperative Blood Transfusion

Incidence of Wound Sepsis

Incidence of Adverse Effects

Full Information

NCT ID

NCT02083107

First Posted

March 7, 2014

Last Updated

November 22, 2015

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02083107

Brief Title

Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Official Title

COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage, Intrapartum blood loss, Misoprostol

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

636 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sublingual misoprostol & rectal placebo

Arm Type

Experimental

Arm Description

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

Arm Title

rectal & sublingual placebo

Arm Type

Placebo Comparator

Arm Description

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

Arm Title

rectal misoprostol & sublingual placebo

Arm Type

Experimental

Arm Description

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Misotac, Cytotec

Intervention Description

Comparison of different routes of administration of 400 micro gram misoprostol

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Intraoperative Blood Loss

Time Frame

from start of cesarean section till the end of operation (average one hour)

Secondary Outcome Measure Information:

Title

Need for Extra Ecbolics (Oxytocin).

Time Frame

from start of cesarean section till the end of operation (average one hour)

Title

APGAR Score

Description

Time Frame

1minute and 5 minutes from delivery of the fetus

Title

Time to Resume Bowel Habits

Time Frame

average 24 hours

Title

Need for Extra Analgesics

Time Frame

average 24 hours

Title

Need for Postoperative Blood Transfusion

Time Frame

average 24 hours

Title

Incidence of Wound Sepsis

Time Frame

upto one week

Title

Incidence of Adverse Effects

Time Frame

24 hours

Other Pre-specified Outcome Measures:

Title

Change in Hemoglobin Concentration

Time Frame

24 hours postoperative from baseline hemoglobin

Title

Change in Hematocrite Value

Time Frame

24 hours postoperative from baseline hematocrite value

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients booked for elective cesarean section. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section Exclusion Criteria: Primigravida. Blood dyscrasias. Large fibroids. Multiple pregnancies. Overdistended uterus eg. Hydramnios. Pre-eclampsia. Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl). Previous history of PPH. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. Placenta previa. Contraindication to spinal anesthesia. Previous myomectomy. Previous two or more C.S.

Overall Study Officials: