Evaluation of the Efficacy of Rectal or Sub-linguinal Misoprostol concomitant with Oxytocin for Prevention of Postpartum Hemorrhage in women with preeclampsia

Evaluation of the efficacy of prophylactic oral misoprostol in comparison with conventiinal treatment for reducing PPH (post-partum hemorrhage) in pre-clampsia Evaluation of the efficacy of prophylactic rectal misoprostol in comparison with conventiinal treatment for reducing PPH (post-partum hemorrhage) in pre-clampsia Evaluation of the efficacy of prophylactic oral and rectal misoprostol for reducing PPH (post-partum hemorrhage) in pre-clampsia

A randomized clinical trial with 2 intercention and 1 control groups, with parellel groups, double blinded, phase 3 on 126 patients, pockent shuffling was used for randomization.

The main researcher patients and data analyzer are blind to the study groups. After randomization with the shuffled pocket method, the patient enters the group at random. After spinal anesthesia with the same protocol and C-section, immediately after the umbilical cord clamp, the first group was injected with 400 micrograms of rectal misoprostol, the second group with 400 micrograms of rectal misoprostol. All groups including the control group only recieve 30 U of Oxytocin according to the national protocol.

Inclusion: Age between 18 to 45 years Pregnant mothers with severe pre-eclampsia Hospitalization for C-section Gestational age over 35 weeks A maximum of 2 previous cesarean sections Complete removal of the placenta after cesarean section Exclusion: Chronic hypertension Placental abnormality Complications or emergent condition during surgery High bleeding risk Indication for hysterectomy or TL

Oral misoprostol Rectal misoprostol Control

Gauzes count for blood loss volume will be performed after the operation, 1 hour, 4 hours after surgery, and hemoglobin and hematocrit will be measured 24 hours after delievery.

Only 126 patients were changed to 128 patients.

Pocket shuffling, In this study for a total sample size of 128, the principle investigator write number 1 on 43 blanck cards, number 2 on 43 blanck cards, number 3 on 43 blanck cards. Then, she place them in non-transparent pockets, then give all of them to another person that will shuffle them and put them in a box and give the box back to PI. For every patients included in the study, the PI picks up one card and assign the patient to one of the 3 groups based on the information on that card. The rest of the cards is then shuffled again and placed in a box to be used by another patient. This continues until the last patient.

First, dark envelopes were prepared for the number of total sample size, the inside of which was not visible in the light, and a paper that the name of groups was written on them were placed in them and placed in the operating room. The surgeon picks up an envelope and gives it to the PI. Based on the information in the envelope, the PI prescribes the medication for the patient. The patients and data analyzer will not know what kind of tratment were prescribed.

Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript

One year after finishing the study, data will be published and will be available in databases

After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes

Other researchers are permitted to included the results in their systematic reviews and metaanalysis

Mina Ataee, Shahid Kamali Hospital, Alborz

After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks