Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 2

Conditions: Hemorrhage Postpartum

Treatments: Drug: Ranitidine Oral Tablet; Drug: Misoprostol Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03140033

MFathy

Details and patient eligibility

About

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

Full description

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.

Enrollment: 158 estimated patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups, including a placebo group

Misoprostol oral tablets

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol Oral Tablet

Ranitidine oral tablets

Placebo Comparator group

Description:

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

Treatment:

Drug: Ranitidine Oral Tablet