Manual Rotation in Persistent Occiput Posterior Position

Sponsor
Ana Catarina Reis de Carvalho (Other)
Overall Status
Unknown status
CT.gov ID
NCT03271957
Collaborator
University of Lisbon (Other)
50
1
10
5

Study Details

Study Description

Brief Summary

Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a persistent OP at delivery. Nevertheless, little is known about the success of this intervention or about the relation of some ultrasound measures with the outcome.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Manual rotation

Detailed Description

Persistent OP at delivery occurs in approximately 10% of fetuses and studies have shown an increase in short-term and long-term maternal and fetal complications such as prolonged labour, maternal exhaustion, fetal distress, instrumental delivery, caesarean delivery and severe perineal tears. Manual rotation of the fetal occiput to OA position has been described as a safe and effective intervention in the setting of labour arrest but evidence is limited.

Therefore, the investigators aim to evaluate:
  1. The success of manual rotation of the fetal occiput in OP in 2nd stage of labour; The relation of progression angle (PA) accessed by ultrasound and the success of manual rotation; This is as prospective study with a sample size calculated of 50 participants.

  2. º Identify an OP position during digital examination in the first evaluation at full cervical dilatation (t=0)

  3. º Get informed consent from the pregnant woman.

  4. º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)

  5. º Confirm fetal head position by ultrasound and measure PA.

  6. º Attempt a manual rotation to anterior position accordingly to the protocol.

  7. º Confirm fetal head position by ultrasound.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position
Anticipated Study Start Date :
Oct 1, 2017
Anticipated Primary Completion Date :
Feb 27, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Success of manual rotation of the fetal occiput in OP in 2nd stage of labour [This outcome will be measure immediately after the attempt of manual rotation]

    After the attempt of manual rotation we will confirm if the fetal occiput, initially in Occiput-posterior (OP) position, is now in Occiput-anterior position (successful rotation) or if is still in OP position (unsuccessful rotation). This confirmation will be made through ultrasound observation.

Secondary Outcome Measures

  1. Impact of ultrasound measures (progression angle (PA) and dorsal fetal position) [The PA and dorsal fetal position will be measure after the diagnose of full dilatation when occurs the first urge to push or 30 minutes after the diagnose of full dilatation (multiparous) or 60 minutes after the diagnose of full dilatation (nulliparous)]

    The relation of PA and dorsal fetal position accessed by ultrasound and the success of manual rotation;

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Singleton pregnancies

  • 37 weeks of pregnancy

  • Fetus in cephalic presentation

  • Fetal weight estimation P10-90

  • Fetal head in a posterior position in the moment of full cervical dilatation.

Exclusion Criteria:
  • do not give or do not be able to give written consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte Lisboa Portugal 1600

Sponsors and Collaborators

  • Ana Catarina Reis de Carvalho
  • University of Lisbon

Investigators

  • Study Director: Nuno Clode, MD, Obstetrics' Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ana Catarina Reis de Carvalho, Resident, University of Lisbon
ClinicalTrials.gov Identifier:
NCT03271957
Other Study ID Numbers:
  • ManualRotationULisbon
First Posted:
Sep 5, 2017
Last Update Posted:
Sep 5, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 5, 2017