Investigation of the effects of vaginal probiotic capsules on prolonging the time of membrane rupture up to delivery and on maternal and fetal complications.

Investigation of the effects of vaginal probiotic capsules on prolonging the time of membrane rupture up to delivery and on maternal and fetal complications

In this study, 64 pregnant women who have the inclusion criteria and refer to Ghaem, Emam Reza and Ommolbanin hospitals are chosen. Participants are randomly divided to intervention and control group (Randomization is done by computer).

Regarding that the most important factor in neonatal death is Preterm delivery, and on the other hand the reason of 35 percent of these Preterm delivery is preterm membrane rupture and also due to the fact that after delivery, the more the age, the less the complications related to preterm infant, in this study. Therefore, with the prescription of vaginal probiotic capsules and maintaining normal vaginal microbial flora, it is aimed to increase pregnancy age and reduce the complications of being preterm. This study will be carried out in Ghaem, Emam Reza and Ommolbanin hospitals in Mashhad. No blinding is done and patients are randomly divided to two groups.

Inclusion criteria: live singleton pregnancy, being pregnant for 24 to 32 weeks, no symptoms of chorioamniotic, no sign of fetal distress, no vaginal bleeding, consent of mothers to participate in the study. Exclusion criteria: sings of chorioamniotic, disturbed fetal health assessment test, vaginal bleeding, unwillingness of patients to continue participating in the study.

for randomization, two equal sets of green and blue cards are provided and placed in envelopes (Randomization is done by computer). An envelope will be allocated to each patient. In both green and blue groups, the awaiting treatment is carried out as following: In the first 48 hours of hospitalization, 2 grams of intravenous Ampicillin injection per 6 hours and then for a week, 500-milligram Amoxicillin capsules per 8 hours and 400-milligram Erythromycin pills per 6 hours are prescribed. Also two doses of 12-milligram intramuscular Betamethasone injection within 24 hours is prescribed. Mother's vital signs and fetus health are precisely controlled through daily NST, sonography twice a week and CBC every other day. Additionally for patients who have green sets of cards, during this period of time, one vaginal probiotic capsule made by ZIST TAKHMIR company is prescribed daily for 10 days.2 weeks after delivery, infants and mothers in both groups will be still be followed.

Main outcomes: duration of awaiting treatment and pregnancy age at the time of delivery

for randomization, two equal sets of green and blue cards are provided and placed in envelopes (Randomization is done by computer). An envelope will be allocated to each patient.

All data can be shared after patients are made unidentifiable.

Data can be accessible 6 months after results are published.

Data will be available for researchers in universities and other scientific institutes.

Carrying out analysis on data is permitted.

Data can be accessible through sending an email to the corresponding author.

After sending a request email to the corresponding author, data will be sent in 1 month.