Clinical Implications of Fetal Positioning During Delivery

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Position and Presentation Abnormalities
• Intervention / Treatment: Other: n a

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Magdalena Witkiewicz, BA; Phone Number: 603 404 799; Email: magdawitkiewicz@o2.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-004
      • Recruiting
      • Żelazna Medical Centre, LLC
      • Contact: Baranowska Baranowska, PhD; Phone Number: 509083263; Email: bbaranowska@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.	immediately after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of delivery	the time of 1,2,3 and 4 stage of labor	immediately after birth
Uterine contractions	uterine contractions as measured by number of contractions and assessment of uterine contractile coordination	during birth
Labor progress	Labor progress as measured by assessment of the head insertion, advancement in the birth canal,	during birth
Epidural	as measured by epidural or not	immediately after delivery
Perineum injury	as measured by number and extent of injury	immediately after delivery
Episiotomy	as measured by episiotomy or not	immediately after delivery
Methods of placental separation	as measured by number of Duncan or SchultZ methods	immediately after delivery
Blood loss	postpartum blood loss (ml)	immediately after delivery
Difficulty of childbirth	difficulty of childbirth as measured by subjective assessment of the woman and the midwife	immediately after delivery

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC
• Collaborators: Foundation for St. Sophia Specialist Hospital in Warsaw
• Investigators: Study Chair: Baranowska Baranowska, PhD, Żelazna Medical Centre, LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: fetal malposition; fetal left occiput position; fetal right occiput position
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: PN/29/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No