Manual Rotation in Persistent Occiput Posterior Position

NCT ID: NCT03271957

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-08-01

Brief Summary

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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.

Detailed Description

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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.

1. º Identify an OP position during digital examination in the first evaluation at full cervical dilatation (t=0)
2. º Get informed consent from the pregnant woman.
3. º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)
4. º Confirm fetal head position by ultrasound and measure PA.
5. º Attempt a manual rotation to anterior position accordingly to the protocol.
6. º Confirm fetal head position by ultrasound.

Conditions

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Manual Rotation of A Liveborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Manual rotation

Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Lisbon

OTHER

Sponsor Role collaborator

Ana Catarina Reis de Carvalho

OTHER

Sponsor Role lead

Responsible Party

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Ana Catarina Reis de Carvalho

Resident

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nuno Clode, MD

Role: STUDY_DIRECTOR

Obstetrics' Director

Locations

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Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte

Lisbon, , Portugal

Site Status

Countries

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Portugal

Central Contacts

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Catarina R de Carvalho

Role: CONTACT

+351919297913

Catarina R de Carvalho

Role: CONTACT

Facility Contacts

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Catarina Reis Carvalho, resident

Role: primary

+351919297913

Other Identifiers

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ManualRotationULisbon

Identifier Type: -

Identifier Source: org_study_id

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