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IRCT20090719002204N5 IRCT 2024-08-20 Ahvaz University of Medical Sciences The effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP): A randomized controlled trial The effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP): A randomized controlled trial 2024-09-22 anticipated 52 Complete https://irct.ir/trial/78571 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the samples, we will use the "permutation block randomization" method using a reliable website to generate random sequences. 52 samples are assigned to two intervention (26 people) and control (26 people) groups. The random block sequence to determine the groups will be randomly generated using the randomization website www.sealedenvelope.com. The size of the blocks in this study will be different (4 blocks and 8 blocks) in order to create more variety in the allocation of samples. N/A Position of the posterior occiput of the fetal head. Intervention 1: Intervention group: pelvic movements with birth ball. In the intervention group, from dilation of 4 cm and in case of having three spontaneous contractions of the uterus in ten minutes with a duration of at least 40 seconds, pelvic exercises with a birthing ball will be started in such a way that the mother will spread her legs shoulder-width apart and sit on the ball. For safety and to prevent falling, he will hold the protective bar next to the bed with both hands. The researcher will also be behind him for more assurance. Pelvic movements on the ball will be circular movements and the direction of rotation will be determined by the position of the fetal head. Since the main objective of our study is the rotation of the fetal head towards the mother's front (OA); Therefore, in left posterior occiput (LOP) fetuses, the direction of pelvic rotation will be to the right (clockwise) and in right posterior occiput (ROP) fetuses, the direction of pelvic rotation will be to the left (counterclockwise). Intervention 2: Control group: routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is no information
public Dr. Somayeh Makavndi
Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794. +98 916 604 2247 somayemakvandi@gmail.com Ahvaz University of Medical Sciences scientific Dr. Somayeh Makvandi
Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794. +98 916 604 2247 somayemakvandi@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Being interested in participating in the study age of at least 18 years and a maximum of 45 years low-risk pregnancy able to understand the Persian language primiparous and multiparous women singleton fetus in vertex presentation intact membranes not suffering from diseases chronic gestational age 37 to 42 weeks normal pelvic examination (to remove the bias, all examinations will be performed by an experienced person with 20 years of clinical work in the maternity hospital) 4 cm dilation of the cervix having at least three spontaneous uterine contractions of 40 seconds in ten minutes spontaneous start of labor estimation of fetal weight based on late pregnancy ultrasound between 2500 and 4000 grams/ position of the posterior occiput of the fetus during hospitalization in the active phase 18 years 45 years Female previous cesarean Occurrence of any dangerous symptoms that risk labor and require medical intervention Withdrawal at any time from the study O64.0 Obstructed labor due to incomplete rotation of fetal head Treatment - Devices N/A Intervention group: pelvic movements with birth ball. In the intervention group, from dilation of 4 cm and in case of having three spontaneous contractions of the uterus in ten minutes with a duration of at least 40 seconds, pelvic exercises with a birthing ball will be started in such a way that the mother will spread her legs shoulder-width apart and sit on the ball. For safety and to prevent falling, he will hold the protective bar next to the bed with both hands. The researcher will also be behind him for more assurance. Pelvic movements on the ball will be circular movements and the direction of rotation will be determined by the position of the fetal head. Since the main objective of our study is the rotation of the fetal head towards the mother's front (OA); Therefore, in left posterior occiput (LOP) fetuses, the direction of pelvic rotation will be to the right (clockwise) and in right posterior occiput (ROP) fetuses, the direction of pelvic rotation will be to the left (counterclockwise). Control group: routine care Frequency of anterior rotation of the fetal head. Timepoint: Every two hours. Method of measurement: Portable ultrasound. Cervical dilatation process. Timepoint: Every two hours. Method of measurement: Vaginal examination. Cervical effacement process. Timepoint: Every two hours. Method of measurement: Vaginal examination. First labor stage duration. Timepoint: at end of the first stage. Method of measurement: Partograph. Labor pain. Timepoint: every 2 hours. Method of measurement: visual analogue scale. Persistent posterior occiput. Timepoint: At the time of delivery. Method of measurement: observation. Ahvaz University of Medical Sciences Approved 2024-07-20 Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences Golestan Ahvaz Khouzestan Iran (Islamic Republic of)