Clinical Implications of Fetal Positioning During Delivery

Fetal Position and Presentation Abnormalities Clinical Trial

Official title:

Clinical Implications of Fetal Positioning During Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813237
• Other study ID #: PN/29/2020
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: Zelazna Medical Centre, LLC
• Contact: Magdalena Witkiewicz, BA
• Phone: 603 404 799
• Email: magdawitkiewicz[@]o2.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Position and Presentation Abnormalities

Intervention

Other:
• n a
the participants are not subjected to any type of intervention

Locations

Country	Name	City	State
Poland	Zelazna Medical Centre, LLC	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC	Foundation for St. Sophia Specialist Hospital in Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of delivery	Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.	immediately after delivery
Secondary	Duration of delivery	the time of 1,2,3 and 4 stage of labor	immediately after birth
Secondary	Uterine contractions	uterine contractions as measured by number of contractions and assessment of uterine contractile coordination	during birth
Secondary	Labor progress	Labor progress as measured by assessment of the head insertion, advancement in the birth canal,	during birth
Secondary	Epidural	as measured by epidural or not	immediately after delivery
Secondary	Perineum injury	as measured by number and extent of injury	immediately after delivery
Secondary	Episiotomy	as measured by episiotomy or not	immediately after delivery
Secondary	Methods of placental separation	as measured by number of Duncan or SchultZ methods	immediately after delivery
Secondary	Blood loss	postpartum blood loss (ml)	immediately after delivery
Secondary	Difficulty of childbirth	difficulty of childbirth as measured by subjective assessment of the woman and the midwife	immediately after delivery