Comparative Study of the effect of Flobel Syrup with Magnesium Hydroxide Syrup in the treatment of constipation in pregnant women: A Randomized Clinical Trial

Comparison of the effect of Flobel syrup with magnesium hydroxide syrup in the treatment of constipation in pregnant women referred to Mobini Sabzevar Hospital.

کارآزمایی بالینی دارای گروه کنترل و مداخله موازی، یک سویه کور، تصادفی شده، فاز 3، بر روی 70 بیمار،تعیین بلوک های تصادفی با کمک نرم افزارRandom Allocation انجام می شود.

This study will be conducted in 1403 at Mobini Hospital in Sabzevar city, Razavi Khorasan, Iran. In the control group, magnesium hydroxide syrup and in the intervention group, Flobel syrup. First, eligible pregnant mothers are selected by gynecologists and entered into the study. In the intervention group, the patient consumes Flobel syrup twice a day in the amount of one tablespoon equivalent to 10 cc for two weeks. If constipation does not improve, patients can increase the dose of medicine up to 30 cc daily. In the control group, the patient consumes 30-60 cc of magnesium hydroxide daily.

Entry requirements: Age 15-45 years Gestational age 5 to 35 weeks Diagnosing constipation based on ROME IV criteria (having bowel movements less than 3 times a week, pain during defecation and hard stools). Non-entry conditions: high risk pregnancy History of inflammatory bowel diseases Having a history of bowel surgery Smoking and drug abuse Use of other laxatives

The control group will use magnesium hydroxide syrup and the intervention group will use Flobel syrup. First, pregnant mothers referring to the women's clinic of Mobini Hospital of Sabzevar University of Medical Sciences with complaints of constipation (based on ROME IV criteria) who are eligible to enter the project are selected by gynecologists and entered into the study.

Frequency of bowel movements per week was the primary outcome.

Block randomization method (permuted block randomization) patients are assigned to two intervention and control groups. Considering that we are supposed to have 35 samples in each group (70 people in total), we use 7 blocks of 10 members for this purpose. Inside each block, 5 people are assigned to the intervention group and 5 people to the control group. Random blocks are determined with the help of Random Allocation software. In order to hide the random allocation, we will use opaque sealed envelopes with a random sequence. In this method, after creating a random sequence with the help of the software, a number of envelopes are prepared based on the sample size, each of the created random sequences is recorded on cards and placed inside the envelopes (every 10 envelopes corresponding to is a block). Then, based on the order of entry of eligible participants into the study, one of the envelopes related to the desired block is opened and the group assigned to the patient is determined. For the purpose of blinding, random allocation will be made with irregular codes and a combination of numbers and letters, and these codes will be recorded on the envelopes instead of numbers, so that the researcher cannot, when preparing the envelopes, due to the irregular codes on the envelopes. Guess the designated group inside the envelope. It will not be known to the patients what medicine they will receive and thus blinding will be done

Considering that we are supposed to have 35 samples in each group (70 people in total), we use 7 blocks of 10 members for this purpose. Inside each block, 5 people are assigned to the intervention group and 5 people to the control group. In order to hide the random allocation, we will use opaque sealed envelopes with a random sequence. In this method, after creating a random sequence with the help of the software, a number of envelopes are prepared based on the sample size, each of the created random sequences is recorded on cards and placed inside the envelopes (every 10 envelopes corresponding to is a block). Then, based on the order in which the eligible participants entered the study, one of the envelopes related to the desired block is opened and the group assigned to the patient is determined. For the purpose of blinding, random allocation will be made with irregular codes and a combination of numbers and letters, and these codes will be recorded on the envelopes instead of numbers, so that the researcher cannot, when preparing the envelopes, due to the irregular codes on the envelopes. Guess the designated group inside the envelope. It will not be known to the patients what medicine they will receive and thus blinding will be done.