An interventional study of maternal modified sims position and maternal free positions in Persistent Occiput Posterior Position During Labor, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-05.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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.
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
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Maternal Modified Sims position during at least 40 minutes for each 60 minutes
At least 40 minutes each hour during labour
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.
Time frame: During labour
rotating to OA
length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention
Time frame: During labour
Delivery mode
eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous
Time frame: The first two hours after delivery
uterine dynamics
assessed by frequency and intensity according to Monteviedo unit calculation
Time frame: During labour
first stage in minutes
timed in minutes, from 3cm with cervix shortened until complete diltation.
Time frame: During labour
second stage in minutes
timed from complete dilation to foetal head expulsion
Time frame: The first two hours after delivery
epidural anaesthesia
doses of epidural anaesthesia required, concentration and ml.
Time frame: During labour
episiotomy
whether performed or not to gain a major opening from the soft parts of the birth canal.
Time frame: The first two hours after delivery
tear
trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:
Time frame: The first two hours after delivery
reason to end labour earlier
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
Time frame: The first two hours after delivery
maternal comfort during labour
MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish
Time frame: The first two hours after delivery
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute