Labor Pain
Conditions
Keywords
Maternal Position, Left Lateral Position, Active Phase of Labor, Randomized Controlled Trial
Brief summary
This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.
Detailed description
Globally, maternal positioning during labor is a key component of humanized childbirth. While the World Health Organization recommends allowing women to adopt comfortable positions, the supine position remains prevalent in many clinical settings for practitioner convenience. This study in Honduras seeks to generate local evidence on the impact of maternal position on labor progression. Nulliparous women at term (≥37 weeks) with a singleton pregnancy in cephalic presentation and in the active phase of labor (≥6 cm dilation) will be recruited from the labor and delivery unit of the Hospital Materno Infantil. After providing informed consent, participants will be randomized. The primary efficacy endpoint is the time from the onset of the active phase (or intervention start, if later) until delivery. The study hypothesizes that the left lateral position will significantly reduce active labor duration compared to the supine position, potentially reducing unnecessary surgical interventions and improving the childbirth experience.
Interventions
OTHERLeft Lateral Decubitus Group
Participants will be placed in the left lateral decubitus position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.
Participants will remain in the supine position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.
Sponsors
Universidad Nacional Autonoma de Honduras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The groups will be labeled "AGroup" and "B Group" during data collection and tabulation. The statistician performing the analysis will be blinded to which group corresponds to which intervention until the analysis is complete.
Intervention model description
This is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio. It employs a superiority framework to test the hypothesis that the left lateral decubitus position is superior to the standard supine position for reducing the duration of the active phase of labor. The design is single-blind, where the outcome assessors and data analysts are masked to group assignment. Due to the physical nature of the intervention (maternal positioning), participants and the healthcare providers implementing the position cannot be blinded. This is a single-center efficacy trial conducted in a real-world hospital labor and delivery setting.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed and dated informed consent form. * Nulliparous woman. * Singleton pregnancy at ≥37 weeks of gestation. * Intact amniotic membranes. * Cephalic presentation. * In the active phase of labor (cervical dilation ≥6 cm). * Age ≥18 years. * No contraindication for vaginal delivery. * Possession of a mobile phone (for potential follow-up contact).
Exclusion criteria
* Previous uterine surgery. * Maternal condition preventing vaginal delivery. * Fetal anomaly. * Premature rupture of membranes. * Multiple pregnancy. * Fetal demise. * Uterine myomas. * Maternal comorbidities (e.g., chronic hypertension, diabetes mellitus type -1/2/gestational, hypothyroidism). * Anemia. * Age \<18 years. * Preterm gestation (\<37 weeks).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the active phase of labor. | Time (in minutes) from the diagnosis of the active phase of labor (cervical dilation ≥6 cm) to delivery of the newborn. Within the first 24 hours after diagnosis of active phase. | The primary objective is to measure and compare the time taken to progress from the active phase to delivery between the two positioning groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cesarean Delivery | From randomization until delivery (anticipated within 48 hours per participant). | The proportion of participants in each group who undergo a cesarean section. |
| Use of Oxytocin for labor augmentation/conduction. | From randomization until delivery. | The proportion of participants in each group who receive oxytocin infusion. |
| Incidence of maternal complications (e.g., perineal tears, hemorrhage, hypotension). | From randomization until hospital discharge (approximately 24-48 hours postpartum). | Composite of adverse maternal outcomes recorded during labor and the immediate postpartum period. |
| Neonatal status as measured by Apgar score. | At 1 minute and 5 minutes after birth. | The Apgar score (0-10) will be recorded and compared between groups. |
Countries
Honduras
Contacts
CONTACTRicardo A. Gutierrez Ramirez, MD, MSc
Outcome results
None listed