Hemorrhage Postpartum
Conditions
Brief summary
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
Detailed 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.
Interventions
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
DRUGRanitidine Oral Tablet
at cord clamping the patient will recieve ranitidine sublingually
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss during cesarean sections | through study completion, an average of 1 year | Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure and pulse | through study completion, an average of 1 year | Change in blood pressure and pulse before and after the cesarean section |
| Blood loss after 24 hr. | through study completion, an average of 1 year | The allowable blood loss (ABL) =\[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) \] / HI ( initial hematocrit) |
| Need for additional uterotonic agent | through study completion, an average of 1 year | Need for additional uterotonic agent e.g oxytocin - methyl ergotamine |
| Vaginal bleeding | through study completion, an average of 1 year | 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 |
| Need for surgical measures to stop bleeding | through study completion, an average of 1 year | Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy |
| Side effects of misoprostol | through study completion, an average of 1 year | Nausea, Vomiting or Diarrhea |
| Need for blood transfusion | through study completion, an average of 1 year | number of patients receiving blood transfusion |
Countries
Egypt
Contacts
Primary ContactMohamed H Fathy, M.B.B.Ch
Backup ContactAmr YEHIA, MD,MRCOG
Outcome results
None listed