Condition category
Pregnancy and Childbirth
Date applied
22/05/2016
Date assigned
01/07/2016
Last edited
07/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
As the volume of the abdomen increases during pregnancy, lying belly down is increasingly difficult and uncomfortable, so we have developed a special stretcher so that the pregnant woman can remain in that position during any stage of pregnancy. The stretcher has a hole in it, support for the head and a convex shape (half-moon) to improve back relaxation. As such a stretcher did not exist before this study, we wish to confirm whether placing the pregnant woman lying belly down would cause any problems in terms of heart rate, respiratory (breathing) rate, blood pressure and discomfort, and also to check the heart rate of their babies.

Who can participate?
Healthy pregnant and non-pregnant women aged between 20 and 34

What does the study involve?
Participants are randomly allocated to lie in one of two sequences of positions on the prototype stretcher. In each position we measured the participants' heart rate, respiratory (breathing) rate, blood pressure and any discomfort, and the heart rate of the babies.

What are the possible benefits and risks of participating?
In the future this stretcher could be used for pregnant women undergoing spinal surgery or for a physiotherapy session. The possible benefits for them would be feeling comfortable because this stretcher improves back relaxation and oxygenation.The possible risks would be the pregnant woman reporting discomfort or pain during positioning with some changes of normal values in heart rate, respiratory rate and blood pressure.

Where is the study run from?
Department of Obstetrics, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP, Brazil

When is the study starting and how long is it expected to run for?
April 2012 to March 2013

Who is funding the study?
Department of Obstetrics, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP, Brazil

Who is the main contact?
Dr Cláudia de Oliveira
claufisio2005@yahoo.com.br

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudia Oliveira

ORCID ID

http://orcid.org/0000-0002-3130-4061

Contact details

AVENIDA ALMIRANTE COCHRANE 72
102
Santos
11040000
Brazil
+55 (0)13 997823389
claufisio2005@yahoo.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Influence of prone position on a stretcher for pregnant women in maternal and fetal hemodynamic parameters and comfort of the pregnant woman

Acronym

Study hypothesis

Due to the increase of the abdominal volume, the prone position is a difficult and uncomfortable position for pregnant women. Hence, so far, it has not been tested if, in this position, a pregnant woman would have her maternal fetal hemodynamic parameters altered. The present study aims to analyze the influence of the prone position in maternal-fetal hemodynamic parameters and the comfort of the pregnant woman on a prototype stretcher specially built for pregnant women.

Ethics approval

Ethics committee Hospital das Clinicas - Universidade de São Paulo, 13/03/2012, Ref: 0843-11

Study design

Randomised cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Maternal and fetal hemodynamic parameters

Intervention

After collecting the sociodemographic data, the women were asked to lie in each of the following positions on the special stretcher for 6 minutes: supine position (SP) with a 15-degree tilt, left lateral (LL) position with support for the lower limbs, prone position (PP) with a cervical support in the stretcher, and Folwer position (FP), i.e., semi-upright with slightly flexed knees and a 45° support placed behind the back.

The participants in the pregnant group (PG) and the non-pregnant group (NPG) were divided into two subgroups depending on the order of the patients’ positions on the special stretcher: PGS1 (pregnant group sequence one); PGS2 (pregnant group sequence two), NPGS1 (non-pregnant group sequence one) and NPGS2 (non-pregnant group sequence two).

We defined two types of position sequences. Sequence 1 was FP, PP, SP, LL, FP, SP, PP and LL, and sequence 2 was FP, PP, LL, SP, FP, LL, PP and SP. The patients were randomized to perform sequence 1 or 2 (the randomization list was created on 03/04/2012). The order of the components of these two sequences was changed eight times to determine whether the order produced any significant variations in the following parameters in the PG and NPG patients: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP) and respiratory rate (RR). In addition, any significant variations in the baseline fetal HR and fetal variability indexes in the PG in response to changing the order of the sequences was determined.

All volunteers were analyzed in a single moment. Each participant was asked to lie on the special stretcher, where they remained in a sitting position for 10 minutes to stabilize the hemodynamic parameters in a calm environment with a mild temperature. All of the women and fetuses were monitored during this process.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. The maternal hemodynamic indexes:
1.1. Heart rate (HR)
1.2. Oxygen saturation (SpO2)
1.3. Systolic blood pressure (SBP)
1.4. Diastolic blood pressure (DBP)
1.5. Respiratory rate (RR)
Measured using a multiparameter monitor Dixtal, model DX-2020- Campinas-São Paulo-Brazil. The methodology was standardized, and the tensional levels were measured in the left upper arm. The cuff was placed 2.5 cm above the antecubital space. The RR was timed in 1 minute of respiratory cycles (inspiration and expiration).

2. The fetal parameters, such as the fetal HR and uterine contractions, were assessed by fetal cardiotocography performed using non-stress test equipment, model Bistos nº 049-Ribeirão Preto-São Paulo-Brazil.

Secondary outcome measures

Maternal comfort: before shifting to the next position, each participant answered the following questions: Are you comfortable? Have you felt any discomfort in this position? All of the assessments were performed by the same researcher. The simple answer of yes or no was used.

Overall trial start date

05/04/2012

Overall trial end date

10/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy pregnant women between 20 and 34 years of age with singleton pregnancies
2. Gestational age between 20 and 37 weeks
3. No evidence of spinal disease
4. Healthy patients as the non-pregnant women

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

30 pregnant and 16 non-pregnant women

Participant exclusion criteria

Presence of pain and/or discomfort on the special stretcher

Recruitment start date

05/04/2012

Recruitment end date

10/03/2013

Locations

Countries of recruitment

Brazil

Trial participating centre

Universidade de São Paulo
Department of Obstetrics Hospital das Clínicas da Faculdade de Medicina Avenida Doutor Enéas de Carvalho Aguiar, 255; 10° Andar
São Paulo
05403-900
Brazil

Sponsor information

Organisation

Universidade de São Paulo (Brazil)

Sponsor details

Department of Obstetrics and Gynecology
Faculdade de Medicina
Avenida Doutor Enéas de Carvalho Aguiar
255; 10° Andar
São Paulo
05403-900
Brazil
+55 (0)11 26610000
rossana.francisco@hc.fm.usp.br

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Universidade de São Paulo

Alternative name(s)

University of São Paulo, University of Sao Paulo, USP

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Brazil

Results and Publications

Publication and dissemination plan

We are planning to publish the results in June 2016

Intention to publish date

01/06/2016

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN41359519_BasicResults_07Jul16
Included:
1. Participant flow
2. Baseline characteristics
3. Outcome measures

Publication summary

Publication citations

Editorial Notes