Evaluation of the effect of uterine massage on the severity of postpartum hemorrhage after cesarean delivery in low-risk patients

Determining the effect of uterine massage on the severity of postpartum hemorrhage in low risk women compared to routine interventions

A clinical trial with a control group without blinding on 82 patients

After receiving the ethics approval from the Research Ethics Committee of Yasouj University of Medical Sciences and receiving the approval code from the Iranian Clinical Trials Center, 82 eligible patients were selected to enter the study. They are divided into two groups receiving uterine massage (intervention) and not receiving uterine massage (control) with the same number of 41 people in each group. All interventions and procedures of the country will be performed the same in both groups. Due to the nature of uterine massage intervention, it is not possible to blind the researcher and the patient in this study. In case of postpartum hemorrhage, the relevant measures will be taken according to the national protocol and will be recorded in the relevant questionnaires.

Mother's age between 18 to 34 years Absence of severe bleeding during cesarean section Consent of the patient and spouse to participate in the study Absence of underlying disease No emergency caesarean section Singleton pregnancy Gestational age greater than to 28 weeks Being in the low-risk group based on risk factors for postpartum hemorrhage Pre-pregnancy body mass index of the mother less than 30 kg/m2

In the intervention group: performing uterine massage in the form of placing a hand on the patient's lower abdomen and one hand inside the vagina and stimulating the uterus with repetitive movements. In the intervention group: uterine massage is not performed to prevent uterine bleeding.

severity of postpartum hemorrhage after delivery, blood transfusion after delivery, maternal death after delivery

In this study, we will use the limited randomization method of the block randomization type. Blocking is usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps the researchers to ensure that the number of samples allocated to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process. The randomization tool is also used from random sequence generation software, which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. For concealment, we use random allocation concealment, which refers to the method used to perform a random sequence on study participants, in such a way that the allocated group is not known before individual allocation. By using sealed opaque letter envelopes with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box.