NCT02209090

Brief Summary

Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia. Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio. The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

July 2, 2014

Last Update Submit

August 1, 2014

Conditions

Persistent Occiput Posterior Position During Labor

Keywords

occiput-posterioroccipitoposteriorlabour

Outcome Measures

Primary Outcomes (1)

  • Rotation

    the foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.

    During labour

Secondary Outcomes (2)

  • rotating to OA

    During labour

  • Delivery mode

    The first two hours after delivery

Other Outcomes (8)

  • uterine dynamics

    During labour

  • first stage in minutes

    During labour

  • second stage in minutes

    The first two hours after delivery

  • +5 more other outcomes

Study Arms (2)

maternal modified sims position

EXPERIMENTAL

Women in this group will adopt the modified Sims position, lying on the side of the foetal back. This position is maintained for the greater part of labour, at least 40 minutes, every hour. The mother can use other positions during resting time of no more than 20 minutes each hour, but never use a lateral position against the side of the foetal back.

Procedure: maternal modified sims position

maternal free positions

SHAM COMPARATOR

Women can adopt the position they wish and which is most comfortable, except for lateral positions which can only be used for a maximum of 20 minutes each hour to avoid confounding factors.

Procedure: maternal free positions

Interventions

maternal modified sims positionPROCEDURE

Maternal Modified Sims position during at least 40 minutes for each 60 minutes

maternal modified sims position
maternal free positionsPROCEDURE

At least 40 minutes each hour during labour

maternal free positions

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult pregnant women (\>18 years of age)
  • persistent posterior foetal position diagnosed during labour through two vaginal examinations two hours apart.
  • at-term gestations (37 to 42 weeks)
  • women in labour with epidural anaesthesia

You may not qualify if:

  • multiple gestations
  • previous severe foetal malformation diagnosed
  • macrosomic foetus diagnosed by ultrasound in the 3rd trimester (\> percentile 95), or IUGR (\< percentile 10)
  • women with contraindicated vaginal delivery owing to previous vaginal surgeries
  • women with severe heart diseases
  • diabetic pregnant women (types I, II and gestational)
  • hypertension problems during labour
  • myopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),

Barcelona, Barcelona, Spain

RECRUITING

Related Publications (1)

  • Bueno-Lopez V, Fuentelsaz-Gallego C, Casellas-Caro M, Falgueras-Serrano AM, Crespo-Berros S, Silvano-Cocinero AM, Alcaine-Guisado C, Zamoro Fuentes M, Carreras E, Terre-Rull C. Efficiency of the modified Sims maternal position in the rotation of persistent occiput posterior position during labor: A randomized clinical trial. Birth. 2018 Dec;45(4):385-392. doi: 10.1111/birt.12347. Epub 2018 Mar 14.

    PMID: 29537658DERIVED

Study Officials

  • Vanessa Bueno, PhDcandidate

    HUValldebronRI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Bueno, Midwife

CONTACT

vanessabuenolopez@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

August 5, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

ES(1)