]>
IRCT20200112046087N8 IRCT 2023-06-15 Shahid Beheshti Faculty of Traditional Medicine Investigating the effect of vagiline cream on facilitating childbirth Investigating the effect of vagiline cream on the facilitation and outcomes of childbirth 2023-03-21 anticipated 70 Complete https://irct.ir/trial/64461 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 Facilitate childbirth. Intervention 1: Intervention group: use of Vagiline cream formulated and standardized in the Medical Research and Terminology Center to soften the cervix by the size of a finger in order to facilitate and speed up the opening of the cervix in order to let the baby out every one hour up to six stages by the midwife, check the cervix every hour up to six stages (to check effacement, engagement, and dilatation), and fill in the table of measurements. Intervention 2: Control group: checking the cervix every one hour up to six stages by a midwife (to check effacement, engagement, and dilatation) and filling in the table of measurements without using any intervention. Yes - There is a plan to make this available What will be shared: The questionnaires used and the information related to the main outcome will be shared with the applicants. When: Start the access period at least one month after the results are published To whom: Researchers Conditions: After the publication of the article extracted from the clinical trial, the said person will notify his / her request by email or contact. Where to obtain: Dr. Mojgan Tansaz Email: tansaz_mojgan@yahoo.com Phone: 02188773525 How to obtain: Sending a request to the main executor of the project, Dr. Mojgan Tansaz, and reviewing the request by her Comments:
public Hanieh Babaei
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 haniehbabaei92@gmail.com Shahid Beheshti School of Traditional Medicine scientific Mojgan Tansaz
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 tansaz_mojgan@yahoo.com Shahid Beheshti School of Traditional Medicine Iran (Islamic Republic of) Singleton Gestational age 40 weeks without onset of labor pains Bishop score below 4 18 years 35 years Female High risk pregnancy Obvious pelvic stenosis Previous caesarean section Rupture of water bag Internal and surgical disorders during pregnancy O80.0 Spontaneous vertex delivery Treatment - Drugs N/A Intervention group: use of Vagiline cream formulated and standardized in the Medical Research and Terminology Center to soften the cervix by the size of a finger in order to facilitate and speed up the opening of the cervix in order to let the baby out every one hour up to six stages by the midwife, check the cervix every hour up to six stages (to check effacement, engagement, and dilatation), and fill in the table of measurements. Control group: checking the cervix every one hour up to six stages by a midwife (to check effacement, engagement, and dilatation) and filling in the table of measurements without using any intervention. Apgar score. Timepoint: The first and fifth minutes. Method of measurement: Using Virginia Apgar's Apgar chart. Duration of onset of labor pains. Timepoint: During childbirth. Method of measurement: Calculation of the time interval between the intervention and the onset of real pain. Shahid Beheshti Faculty of Traditional Medicine Approved 2021-11-28 Ethics committee of Shahid beheshti University of Medical Sciences Shahid Chamran Highway - Yemen St. - Shahid Abbas Aarabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Services Tehran Tehran Iran (Islamic Republic of)