Obstetric; Injury Pelvic Floor, Parturition
Conditions
Keywords
birth, parturition, obstetric lubricant gel, duration of second stage of labor, labor
Brief summary
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.
Detailed description
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
Interventions
COMBINATION_PRODUCTNatalis Obstetric Lubrican Gel
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.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Nulliparous and primiparous singleton pregnancies between 37 and 41 weeks + six days of gestation and vertex presentation of fetus with an estimated birth weight of 2000 - 4500g were included in the study
Exclusion criteria
* Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The duration of the active phase of the first stage of labor was compared between the study and control groups | 0 to 600 minutes | 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. |
| The duration of the second stage of labor was compared between the study and control groups | 0 to 240 minutes | The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episiotomy rates | Episiotomy is a technique performed during the second stage of labor. | differences between study and control groups |
Outcome results
None listed