Clinical trial NCT04813237: Clinical Implications of Fetal Positioning During Delivery
Official title: Clinical Implications of Fetal Positioning During Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Position and Presentation Abnormalities
Keywords: fetal malposition
fetal left occiput position
fetal right occiput position
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
Collaborators: name: Foundation for St. Sophia Specialist Hospital in Warsaw
First posted: 2021-03-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women coming to the 3rd level hospital with a birth house. During a physiological pregnancy, with no severe coexisting diseases.

Brief summary: The project aims to find a relationship between the positioning of the foetus before and during birth and the results of obstetrics and to determine their incidence in the Polish population. The study will be conducted by combining the use of ultrasound diagnostics, midwives observations during childbirth, analysis of medical documentation and a questionnaire on the activity of examined women. The obtained results will be used to prepare guidelines for the birth in a particular foetus position.

Detailed description: The purpose of the examination is to describe the difficulties associated with delivery in a non-optimal position of the fetus. Initial observations show that such childbirth is perceived as difficult by both the women giving birth and the staff. The aim of the study is to describe the level of difficulty of this labor, expressed as the experience of the woman, as well as all the elements that may affect the difficulty of this labor, for example, slower or no progress in labor, disturbances in systolic function, injuries, the need to use epidural anesthesia, increased blood loss.

Eligibility criteria: Inclusion Criteria:

* during childbirth,
* in a single pregnancy,

Exclusion Criteria:

* pelvic position of the fetus
* in whom labor is induced for reasons other than post-term pregnancy,
* women who came to the hospital in the second stage of labor
* severe diseases mother or foetus.

Primary outcomes:
measure: Mode of delivery
timeFrame: immediately after delivery
Secondary outcomes:
measure: Duration of delivery
timeFrame: immediately after birth
measure: Uterine contractions
timeFrame: during birth
measure: Labor progress
timeFrame: during birth
measure: Epidural
timeFrame: immediately after delivery
measure: Perineum injury
timeFrame: immediately after delivery
measure: Episiotomy
timeFrame: immediately after delivery
measure: Methods of placental separation
timeFrame: immediately after delivery
measure: Blood loss
timeFrame: immediately after delivery
measure: Difficulty of childbirth
timeFrame: immediately after delivery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Żelazna Medical Centre, LLC
state: Mazowieckie
Study officials:
affiliation: Żelazna Medical Centre, LLC
name: Baranowska Baranowska, PhD
role: STUDY_CHAIR
References:
citation: Ahmad A, Webb SS, Early B, Sitch A, Khan K, Macarthur C. Association between fetal position at onset of labor and mode of delivery: a prospective cohort study. Ultrasound Obstet Gynecol. 2014 Feb;43(2):176-82. doi: 10.1002/uog.13189.
citation: Matsuo K, Shimoya K, Ushioda N, Kimura T. Maternal positioning and fetal positioning in utero. J Obstet Gynaecol Res. 2007 Jun;33(3):279-82. doi: 10.1111/j.1447-0756.2007.00524.x.
citation: Guittier MJ, Othenin-Girard V, de Gasquet B, Irion O, Boulvain M. Maternal positioning to correct occiput posterior fetal position during the first stage of labour: a randomised controlled trial. BJOG. 2016 Dec;123(13):2199-2207. doi: 10.1111/1471-0528.13855. Epub 2016 Jan 24.
citation: Choi SK, Park YG, Lee da H, Ko HS, Park IY, Shin JC. Sonographic assessment of fetal occiput position during labor for the prediction of labor dystocia and perinatal outcomes. J Matern Fetal Neonatal Med. 2016 Dec;29(24):3988-92. doi: 10.3109/14767058.2016.1152250. Epub 2016 Mar 7.
citation: Khan KS. Optimal fetal positioning: a theory in tatters-time to rewrite textbooks. BJOG. 2016 Dec;123(13):2207. doi: 10.1111/1471-0528.13872. Epub 2016 Jan 25. No abstract available.