Investigating the effect of vagiline cream on the facilitation and outcomes of childbirth

Use of Vagiline cream to facilitate and accelerate the delivery of pregnant women

A clinical trial with a control group, with parallel groups, randomized, phase 2 on 70 patients, without blinding. Block randomization with software was used for randomization.

Women who were admitted for the onset of labor pains in the pain room of Taleghani Hospital of Arak University of Medical Sciences and while receiving routine care for proper allocation in groups, their cervix was randomly examined by a midwife every one hour up to six stages per group. The intervention is softened with Vagiline cream. The b-shop score is measured by a sampler once before the intervention and every 2 hours up to 24 hours after the intervention. For the control group, routine interventions will be performed and the same score as the intervention group will be recorded.

A pregnant woman during the 40th week of pregnancy with the criteria of age between 18 and 35 years, singleton, gestational age of 40 weeks without the onset of labor pains, B-shop score below 4, without suffering from internal disorders and surgery during pregnancy, no history of high-risk pregnancy, absence of obvious pelvic stenosis (in internal examination), absence of previous cesarean section and absence of water sac rupture.

Pregnant women in the intervention group will have their cervix softened by a midwife every one hour up to six stages with Vagiline cream and their cervix diameter will be checked, and the control group, without receiving any cream, will be examined every hour up to six stages of the diameter of their cervix.

Bishab score before and after admission, average Apgar score in the first minute and fifth minute of labor in newborns

In this study, we will use the block randomization method, and in this two-group clinical trial, we will have four blocks. For each person who enters the study, a code is obtained from the software, and it is determined which group it belongs to (intervention or control). The work tool is random allocation software, which, in addition to simple randomization, is capable of generating random sequences using the block method. In order to conceal, we use allocation concealment. This method is such that before the allocation of the individual, the allocated group is not known. In this way, we use non-transparent envelopes sealed with a random sequence. In this method, each of the random sequences created is recorded on a card, and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surfaces of the envelopes are numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. Blocking and preparation of envelopes is done by a person not involved in data sampling and analysis; in this way, the person who collects, the person who analyzes, and the participant are informed of the type of intervention received and what group each person belongs to. He has no information.

The questionnaires used and the information related to the main outcome will be shared with the applicants.

Start the access period at least one month after the results are published

Researchers

After the publication of the article extracted from the clinical trial, the said person will notify his / her request by email or contact.

Dr. Mojgan Tansaz Email: tansaz_mojgan@yahoo.com Phone: 02188773525

Sending a request to the main executor of the project, Dr. Mojgan Tansaz, and reviewing the request by her