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Fetal Position and Presentation AbnormalitiesNCT04813237

Clinical Implications of Fetal Positioning During Delivery

An observational study of Fetal Position and Presentation Abnormalities, run by Żelazna Medical Centre, LLC at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
n a
How many people
300 participants
Where
1 sitePoland
Study dates
31 Mar 2021to 30 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • during childbirth,
  • in a single pregnancy,

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Magdalena Witkiewicz, BA contact

603 404 799

magdawitkiewicz@o2.pl

Poland1 site, 1 recruiting

  • Żelazna Medical Centre, LLC

    Warsaw, Masovian Voivodeship, 01-004

    Baranowska Baranowska, PhD, 509083263, bbaranowska@gmail.com

    Recruiting

Other trials in Poland

About this study

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.

Read the 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.

Being tested
n a
Keywords
fetal malposition, fetal left occiput position, fetal right occiput position

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • n aOther

    the participants are not subjected to any type of intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mode of delivery

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

    Measured: immediately after delivery

Secondary outcomes (9)

  1. Duration of delivery

    the time of 1,2,3 and 4 stage of labor

    Measured: immediately after birth

  2. Uterine contractions

    uterine contractions as measured by number of contractions and assessment of uterine contractile coordination

    Measured: during birth

  3. Labor progress

    Labor progress as measured by assessment of the head insertion, advancement in the birth canal,

    Measured: during birth

  4. Epidural

    as measured by epidural or not

    Measured: immediately after delivery

  5. Perineum injury

    as measured by number and extent of injury

    Measured: immediately after delivery

  6. Episiotomy

    as measured by episiotomy or not

    Measured: immediately after delivery

  7. Methods of placental separation

    as measured by number of Duncan or SchultZ methods

    Measured: immediately after delivery

  8. Blood loss

    postpartum blood loss (ml)

    Measured: immediately after delivery

  9. Difficulty of childbirth

    difficulty of childbirth as measured by subjective assessment of the woman and the midwife

    Measured: immediately after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start31 Mar 2021
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813237
Sponsor's protocol ID
PN/29/2020
Status last verified
Apr 2021
First submitted
12 Mar 2021
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 23929533

  • 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.

    PubMed 17578355

  • 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.

    PubMed 26806596

  • 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.

    PubMed 26948718

  • 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.

    PubMed 26810973

Questions about this trial

What is this clinical trial studying?

An observational study of Fetal Position and Presentation Abnormalities, run by Żelazna Medical Centre, LLC at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magdalena Witkiewicz, BA (603 404 799, magdawitkiewicz@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mode of delivery (time frame: immediately after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813237, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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