Clinical trial NCT06670235: Effectiveness of Upright vs. Lithotomy Birthing Position on Maternal and Newborn Outcomes
Official title: Effectiveness of Using Upright Versus Lithotomy Birthing Position on Maternal and Newborn Outcomes: A Quasi Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Outcomes
Newborn Complication
Keywords: Upright birthing position
Lithotomy position
Maternal outcomes in childbirth
Newborn outcomes in labor
Birth position comparison
Labor positions and delivery
Effectiveness of birth positions
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effectiveness of upright versus lithotomy birthing positions on maternal and newborn outcomes. Conducted at the Maternity Teaching Hospital in Erbil City, it employs a quasi-experimental design with 62 women in each group (Intervention and control), comparing outcomes for those encouraged to use upright positions with those in standard lithotomy. Maternal and newborn outcomes will be assessed to provide evidence on how birthing positions impact labor progression, comfort, and delivery results. The findings aim to inform clinical practice and policy, enhancing midwifery care and supporting patient-centered approaches to childbirth. Does the upright birthing position effect on maternal and newborn outcomes? Does the lithotomy birthing position effect on maternal and newborn outcomes? The expected outcomes will decrease the rate of perineal tear , episiotomy , post partum hemorrhage and decreasing the rate of admission to Neonatal Intensive Care Unit (NICU) in newborn.

Detailed description: This quasi-experimental study assesses the impact of upright versus lithotomy birthing positions on maternal and newborn outcomes, aiming to contribute evidence-based recommendations for optimal birthing practices. As childbirth management increasingly prioritizes maternal comfort and positive birth experiences, this research seeks to fill gaps in understanding the clinical efficacy and maternal satisfaction associated with each position.

Conducted at the Maternity Teaching Hospital in Erbil City, the study will recruit 124 pregnant women, divided equally into two groups: one encouraged to adopt upright positions (e.g., squatting) during labor and delivery, and the other following standard lithotomy position practices. A non probability convenience sampling method is employed, with participants meeting specific inclusion criteria such as gestational age, health status, and labor progression factors.

The intervention includes the promotion of upright positions in the experimental group, while both groups receive standardized maternal care. Data on maternal outcomes-such as labor duration, pain levels, and delivery type-and newborn outcomes, including Apgar scores and need for resuscitation, will be collected and analyzed pre- and post-intervention.

The study's goal is to identify whether upright positions correlate with enhanced labor outcomes, reduced intervention rates, and increased maternal satisfaction. Findings are expected to guide clinical guidelines, informing both practitioners and patients on effective, patient-centered birthing positions. This research further aims to influence midwifery education and policy, advocating for practices that align with women's preferences and cultural contexts, ultimately enhancing maternal and neonatal health outcomes through evidence-based childbirth management.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with singleton pregnancies;
* Gestational age ranges from (≥37 to 41+6 weeks);
* Spontaneous labor with no contraindications to upright positions;
* Active phase of first stage labor;
* Age 18-35 years old;
* Normal size fetus with occipito-anterior position;
* Communicate normally and participate voluntary.

Exclusion Criteria:

* Abnormal fetal position (malpresentation) (e,g., persistent occipital-transverse and occipital-posterior position, etc.);
* Risky pregnancy or childbirth complications, such as (preeclampsia, eclampsia, heart disease, cephalic presentation dystocia, antepartum hemorrhage, fetal distress, intra-uterine growth restriction, intra-amniotic infection); and free from any chronic diseases (heart disease, epilepsy, hypertension, diabetes mellitus and renal disease)
* Multiple gestation;
* Cephalopelvic disproportion (CPD);
* Precipitate labor;
* Antenatally diagnosed fetal anomalies;
* Current history of a leg injury, fracture, and deep vein thrombosis.

Primary outcomes:
measure: Maternal Labor Duration
timeFrame: Assessed continuously from the onset of active labor until delivery.
measure: Newborn Apgar score
timeFrame: Immediately after delivery , Assessed at 1 minute , 5 minutes and 10 minutes post-delivery
Secondary outcomes:
measure: Maternal Perception of Pain and Comfort
timeFrame: Assessed during labor (intervals to be specified, e.g., every 2 hours) and immediately after delivery.
measure: Postpartum Hemorrhage (PPH)
timeFrame: Estimated immediately following delivery and up to 2 hours postpartum.
measure: Maternal Satisfaction with the Birth Experience
timeFrame: Assessed within the first 2 hours postpartum, typically before hospital discharge.
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University, Erbil, Kurdistan region 44001
Study officials:
References:
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