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The investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial.
All participants in the study received standard routine antepartum care in the delivery room. Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups.
The participants were divided into two groups based on their parity: nulliparous and primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups using a computer-generated random number table. In this randomized controlled trial, participant allocation was carried out using a computer program to ensure a randomized and unbiased selection process. The randomization procedure was conducted in a double-blind manner, with the study investigators remaining unaware of the allocation until the conclusion of the study. All participants in the study received standard routine antepartum care in the delivery room. Among all patients, 25 participants were lost to follow-up during the study. Consequently, obstetric lubricant gel was applied to patients in the study groups, which included 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. |
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| Control group | No Intervention | obstetric lubricant gel was not applied to patients in the control groups, which had 55 nulliparous and 43 primiparous patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalis Obstetric Lubrican Gel | Combination Product | The obstetric lubricant gel was applied to the vaginal canal with a special applicator at the beginning of the active phase of the labor. The gel used in the study was highly viscose and isotonic with a slight acid pH of 6.0 - 6.7 and contained hydroxyethylcellulose, propylene glycol, glycerin. The gel box contained a sterile syringe (15 ml) and a flexible applicator. |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of the active phase of the first stage of labor was compared between the study and control groups | The active phase of labor begins when the cervical dilation is between 4-6 cm and refers to the time elapsed until full cervical dilation. | 0 to 600 minutes |
| The duration of the second stage of labor was compared between the study and control groups | The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn. | 0 to 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Episiotomy rates | differences between study and control groups | Episiotomy is a technique performed during the second stage of labor. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28325124 | Background | Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, Koc A, Soylemez F. Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. J Obstet Gynaecol. 2017 Aug;37(6):714-718. doi: 10.1080/01443615.2017.1288711. Epub 2017 Mar 21. | |
| 34569413 | Background |
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The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.
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Randomization was performed using a computer program. Accordingly, the study group patients were administered Obstetric gel. The researcher administering Obstetric gel ensured the blinding of healthcare providers and other researchers.
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| Azarkish F, Janghorban R, Bozorgzadeh S, Merbalouchzai F, Razavi M, Badiee M. Effect of lubricant gel on the length of the first stage of labour and perineal trauma in primiparous women. J Obstet Gynaecol. 2022 Jul;42(5):867-871. doi: 10.1080/01443615.2021.1946021. Epub 2021 Sep 27. |