Manual Rotation of A LivebornNCT03271957
Manual Rotation in Persistent Occiput Posterior Position
An observational study of Manual Rotation of A Liveborn, run by Ana Catarina Reis de Carvalho at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Manual Rotation of A Liveborn
- What is being tested?
- Manual rotation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2017to 1 Aug 2018
- 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 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All pregnant women in the delivery room that fulfill the inclusion criteria
Who may be able to join
- 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.
Who cannot join
- do not give or do not be able to give written consent
Trial locations and contacts
1 site in 1 country.
Catarina R de Carvalho contact
Portugal1 site
Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte
Lisbon, 1600
Catarina Reis Carvalho, resident, +351919297913, catarinareiscarvalho@gmail.com
About this study
Official title: Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position
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.
Read the 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:
- 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.
- º Identify an OP position during digital examination in the first evaluation at full cervical dilatation (t=0)
- º Get informed consent from the pregnant woman.
- º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)
- º Confirm fetal head position by ultrasound and measure PA.
- º Attempt a manual rotation to anterior position accordingly to the protocol.
- º Confirm fetal head position by ultrasound.
- Conditions
- Manual Rotation of A Liveborn
- Being tested
- Manual rotation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual rotationProcedure or surgery
Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of manual rotation of the fetal occiput in OP in 2nd stage of labour
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.
Measured: This outcome will be measure immediately after the attempt of manual rotation
Secondary outcomes (1)
Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)
The relation of PA and dorsal fetal position accessed by ultrasound and the success of manual rotation;
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion27 Feb 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual Rotation of A LivebornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ana Catarina Reis de Carvalho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor-investigator, Ana Catarina Reis de Carvalho, University of Lisbon
- Investigators
- Nuno Clode, MD, Study director, Obstetrics' Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271957
- Sponsor's protocol ID
- ManualRotationULisbon
- Status last verified
- Aug 2017
- First submitted
- 17 Jul 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position
- ClinicalTrials.gov ID
- NCT03271957
- Acronym / sponsor ID
- ManualRotationULisbon
- Conditions
- Manual Rotation of A Liveborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ana Catarina Reis de CarvalhoUniversity, hospital or other
- Collaborators
- University of Lisbon
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 27 Feb 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- º Identify an OP position during digital examination in the first evaluation at full cervical dilatation (t=0)
- º Get informed consent from the pregnant woman.
- º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)
- º Confirm fetal head position by ultrasound and measure PA.
- º Attempt a manual rotation to anterior position accordingly to the protocol.
- º Confirm fetal head position by ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women in the delivery room that fulfill the inclusion criteria
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- do not give or do not be able to give written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual rotationRotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care | Procedure or surgery | – |
Primary outcome
Success of manual rotation of the fetal occiput in OP in 2nd stage of labour
Time frame: 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.
1 secondary outcome
Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina R de Carvalho contact
Nuno Clode, MD study director
Obstetrics' Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Manual Rotation of A Liveborn, run by Ana Catarina Reis de Carvalho at 1 site in Portugal.
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 5 inclusion and 1 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 5 Sep 2017. 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 Portugal. 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 Catarina R de Carvalho (+351919297913, catarinareiscarvalho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of manual rotation of the fetal occiput in OP in 2nd stage of labour (time frame: This outcome will be measure immediately after the attempt of manual rotation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.