The effectiveness of magnesium sulfate vaginal gel on cervical ripening and induction of labor in nulliparous women: a randomized controlled clinical trial

Determining the effect of magnesium sulfate vaginal gel on cervical ripening and induction of labor

The double-blind randomized controlled clinical trial with a total of 174 samples. Samples were randomly selected using computer software (http://www.random.org) through random block sizes of three and six blocks in three groups of 58 people.

This study will be performed in Shahid Taleghani Hospital in Ilam. The study is double-blind and the pregnant woman and the medical staff are kept unaware of the type of treatment. In the first group, magnesium sulfate vaginal gel contains 6 grams of magnesium sulfate, in the second group, magnesium sulfate vaginal gel contains 4 grams of magnesium sulfate, and in the control group, placebo is placed on the cervix through vaginal examination. 4 hours later, all participants are examined. If no change is observed, another dose of the same intervention is performed and re-examined 4 hours later.

Nuliparous, body mass index 18.5-25, post date gestational age, bishop score on arrival less than 4, single fetus with cephalopelvic presentation and intact membranes, low-risk pregnancy and indication for labor induction.

The first group, magnesium sulfate vaginal gel contains 6 grams of magnesium sulfate, in the second group, magnesium sulfate vaginal gel contains 4 grams of magnesium sulfate, and in the control group, placebo contains the same materials used in the gel except magnesium sulfate.

Average bishop score; The amount of misoprostol used; Length of labor; Type of delivery; Frequency of complications; Oxytocin level used, Duration of maternal hospitalization; Apgar score of the first and fifth minutes.

To determine the allocation sequence, 3 and 6 blocking methods with 1: 1 allocation ratio are used. After listing almost all possible states of the blocks and assigning a number to each of them, the assignment sequence will be determined using a computer random number table (using WWW.Randomizer.org). The randomization list is prepared by a statistician. To conceal the type of intervention, it is written on paper and numbered in a series of sealed opaque matte envelopes. By attending the study hospital, the researcher will open an envelope for each research sample in the order of their numbers and the type of intervention will be determined.

Placebo is used in the same shape and packaging as magnesium sulfate gel. Pregnant women and medical staff are kept unaware of the type of treatment provided.