Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-05-31

Brief Summary

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Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

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Detailed Description

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This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Conditions

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Hemorrhage Postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Misoprostol oral tablets

79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping

Group Type ACTIVE_COMPARATOR

Misoprostol Oral Tablet

Intervention Type DRUG

at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually

Ranitidine oral tablets

79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping

Group Type PLACEBO_COMPARATOR

Ranitidine Oral Tablet

Intervention Type DRUG

at cord clamping the patient will recieve ranitidine sublingually

Interventions

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Misoprostol Oral Tablet

at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually

Intervention Type DRUG

Ranitidine Oral Tablet

at cord clamping the patient will recieve ranitidine sublingually

Intervention Type DRUG

Other Intervention Names

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Misotac Ranitak

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancies
* women booked for elective C.S
* full term pregnancies
* primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )

Exclusion Criteria

* blood disorders
* multiple pregnancy
* placenta previa
* polyhydramnios
* marked maternal anemia
* contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
* previous 2 or more C.S

Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes