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Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions (MSIMSFPOP)

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ClinicalTrials.gov Identifier: NCT02209090
Recruitment Status : Unknown
Verified August 2014 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.


Condition or disease Intervention/treatment Phase
Persistent Occiput Posterior Position During Labor Procedure: maternal modified sims position Procedure: maternal free positions Not Applicable

Detailed Description:

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.

Background: There is a theoretical basis for the possible effects of maternal positions on foetal positions. Despite all the studies published in recent years, conclusive trials providing significant scientific evidence are lacking.

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.

Discussion: If the modified maternal Sims position proved to correct persistent foetal occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for both mother and foetus, maternal and foetal morbidity problem would be reduced

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: maternal modified sims position

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

Sham Comparator: maternal free positions
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
At least 40 minutes each hour during labour




Primary Outcome Measures :
  1. Rotation [ Time Frame: During labour ]
    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.


Secondary Outcome Measures :
  1. rotating to OA [ Time Frame: During labour ]
    length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention

  2. Delivery mode [ Time Frame: The first two hours after delivery ]
    eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous


Other Outcome Measures:
  1. uterine dynamics [ Time Frame: During labour ]
    assessed by frequency and intensity according to Monteviedo unit calculation

  2. first stage in minutes [ Time Frame: During labour ]
    timed in minutes, from 3cm with cervix shortened until complete diltation.

  3. second stage in minutes [ Time Frame: The first two hours after delivery ]
    timed from complete dilation to foetal head expulsion

  4. epidural anaesthesia [ Time Frame: During labour ]
    doses of epidural anaesthesia required, concentration and ml.

  5. episiotomy [ Time Frame: The first two hours after delivery ]
    whether performed or not to gain a major opening from the soft parts of the birth canal.

  6. tear [ Time Frame: The first two hours after delivery ]
    trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:

  7. reason to end labour earlier [ Time Frame: The first two hours after delivery ]
    cause that occurs on ending labour before it concludes spontaneously. Reasons may be foetal: risk of loss of foetal wellbeing, or maternal: pelvic foetal disproportion or stopped labour

  8. maternal comfort during labour [ Time Frame: The first two hours after delivery ]
    MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209090


Contacts
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Contact: Vanessa Bueno, Midwife vanessabuenolopez@gmail.com

Locations
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Spain
Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH), Recruiting
Barcelona, Spain
Contact: Vanessa Bueno, Midwife    0034934893086    vanessabuenolopez@gmail.com   
Principal Investigator: Vanessa Bueno, Midwife         
Sub-Investigator: Terré Carmen, PhD         
Sub-Investigator: Casellas Manel, PhD         
Sub-Investigator: Teva Asunción, midwife         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
University of Barcelona
Investigators
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Principal Investigator: Vanessa Bueno, PhDcandidate HUValldebronRI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02209090    
Other Study ID Numbers: PR(AMI)182/2012
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
occiput-posterior
occipitoposterior
labour