Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Hemorrhage Postpartum Clinical Trial

Official title:

Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03140033
• Other study ID #: MFathy
• Status: Recruiting
• Phase: Phase 2
• First received: April 24, 2017
• Last updated: May 2, 2017
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Ain Shams Maternity Hospital
• Contact: Mohamed H Fathy, M.B.B.Ch
• Phone: 00201099984100
• Email: Mohamedfathy31085[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage Postpartum
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol Oral Tablet
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
• Ranitidine Oral Tablet
at cord clamping the patient will recieve ranitidine sublingually

Locations

Country	Name	City	State
Egypt	Ain shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss during cesarean sections	Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta	through study completion, an average of 1 year
Secondary	Vaginal bleeding	Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc	through study completion, an average of 1 year
Secondary	Change in blood pressure and pulse	Change in blood pressure and pulse before and after the cesarean section	through study completion, an average of 1 year
Secondary	Blood loss after 24 hr.	The allowable blood loss (ABL) =[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) ] / HI ( initial hematocrit)	through study completion, an average of 1 year
Secondary	Need for additional uterotonic agent	Need for additional uterotonic agent e.g oxytocin - methyl ergotamine	through study completion, an average of 1 year
Secondary	Need for blood transfusion	number of patients receiving blood transfusion	through study completion, an average of 1 year
Secondary	Need for surgical measures to stop bleeding	Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy	through study completion, an average of 1 year
Secondary	Side effects of misoprostol	Nausea, Vomiting or Diarrhea	through study completion, an average of 1 year