NCT04813237

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

March 12, 2021

Last Update Submit

April 29, 2021

Conditions

Fetal Position and Presentation Abnormalities

Keywords

fetal malpositionfetal left occiput positionfetal right occiput position

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.

    immediately after delivery

Secondary Outcomes (9)

  • Duration of delivery

    immediately after birth

  • Uterine contractions

    during birth

  • Labor progress

    during birth

  • Epidural

    immediately after delivery

  • Perineum injury

    immediately after delivery

  • +4 more secondary outcomes

Interventions

n aOTHER

the participants are not subjected to any type of intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women coming to the 3rd level hospital with a birth house. During a physiological pregnancy, with no severe coexisting diseases.

You may qualify if:

  • during childbirth,
  • in a single pregnancy,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Żelazna Medical Centre, LLC

Warsaw, Masovian Voivodeship, 01-004, Poland

RECRUITING

Related 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.

    PMID: 23929533BACKGROUND

  • 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.

    PMID: 17578355BACKGROUND

  • 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.

    PMID: 26806596BACKGROUND

  • 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.

    PMID: 26948718BACKGROUND

  • 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.

    PMID: 26810973BACKGROUND

Study Officials

  • Baranowska Baranowska, PhD

    Żelazna Medical Centre, LLC

    STUDY CHAIR

Central Study Contacts

Magdalena Witkiewicz, BA

CONTACT

603 404 799magdawitkiewicz@o2.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant at Maternity Ward St. Sophia Specialst Hospital in Warsaw, Principal Investigator

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 24, 2021

Study Start

March 31, 2021

Primary Completion

June 30, 2021

Study Completion

December 30, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

PL(1)