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Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial.

ABSTRACT: BACKGROUND:Prolonged latent phase of labour often results in a traumatic birth experience. Prolonged labour is associated with more operative deliveries, haemorrhage, fetal asphyxia and poor birth experience. Women with prolonged labour in a former pregnancy more often demand caesarean section in the next, due to their negative birth experience. "Proactive support of labour" is an alternative method, developed to counteract prolonged labour. There are little research and no randomized controlled study that compare proactive to standard labour support. METHODS/DESIGN:A prospective, non-blinded, randomized, single-centre, clinical trial where we compare proactive support to standard support of labour in a university hospital setting. INCLUSION CRITERIA:latent phase of labour, non-pathologic pregnancy. Robson group 1, with painful contractions, and fully effaced cervix, with 1-3?cm dilatation. EXCLUSION CRITERIA:induction of labour, breech presentation, twin pregnancy, multi-parity, conditions that require extended surveillance before and/or during labour. PRIMARY OUTCOME:spontaneous, uncomplicated vaginal delivery. After inclusion, women randomized to proactive support of labour will stay at the hospital and have one-to-one midwife support. If no progression during the next 1-2?hours, amniotomy and/or oxytocin stimulation will be started. The control group will adhere to the standard procedures for labour support: expectance until established regular contractions and 4-5?cm cervical dilatation, and then one-to-one midwife support. DISCUSSION:The idea of proactive support of labour is to initiate early intervention when there are signs of slow progress in order to avoid protracted labour with exhaustion of the mother, the uterus and prolonged stress of the foetus. Proactive support of labour may represent a useful method to improve labour support in nulliparous women. However, evidence based on randomized controlled trials are needed in order to know whether proactive support of labour is comparable or superior to standard care. A randomized, controlled trial is described; challenges and possible clinical implications are discussed. TRIAL REGISTRATION:The Proactive Support of Labor Study (PAF) ClinicalTrials, NCT03056313. Registered on February 17, 2017.

SUBMITTER: Brenne Fehn M

PROVIDER: S-EPMC7181587 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial.

Brenne Fehn Møyfrid M Dahlø Raija R Nielsen Renate R Laache Ingebjørg I Vanky Eszter E

Trials 20200423 1

<h4>Background</h4>Prolonged latent phase of labour often results in a traumatic birth experience. Prolonged labour is associated with more operative deliveries, haemorrhage, fetal asphyxia and poor birth experience. Women with prolonged labour in a former pregnancy more often demand caesarean section in the next, due to their negative birth experience. "Proactive support of labour" is an alternative method, developed to counteract prolonged labour. There are little research and no randomized co ...[more]

PMID: 32326956

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Project description:Objective To determine whether being upright in the second stage of labour in nulliparous women with a low dose epidural increases the chance of spontaneous vaginal birth compared with lying down.Design Multicentre pragmatic individually randomised controlled trial.Setting 41 UK hospital labour wards.Participants 3093 nulliparous women aged 16 or older, at term with a singleton cephalic presentation and in the second stage of labour with epidural analgesia.Interventions Women were allocated to an upright or lying down position, using a secure web based randomisation service, stratified by centre, with no masking of participants or clinicians to the trial interventions.Main outcome measures The primary outcome was spontaneous vaginal birth. Women were analysed in the groups into which they were randomly allocated, regardless of position recorded at any time during the second stage of labour (excluding women with no valid consent, who withdrew, or who did not reach second stage before delivery). Secondary outcomes included mode of birth, perineal trauma, infant Apgar score <4 at five minutes, admission to a neonatal unit, and longer term included maternal physical and psychological health, incontinence, and infant gross developmental delay. Results Between 4 October 2010 and 31 January 2014, 3236 women were randomised and 3093 (95.6%) included in the primary analysis (1556 in the upright group and 1537 in the lying down group). Significantly fewer spontaneous vaginal births occurred in women in the upright group: 35.2% (548/1556) compared with 41.1% (632/1537) in the lying down group (adjusted risk ratio 0.86, 95% confidence interval 0.78 to 0.94). This represents a 5.9% absolute increase in the chance of spontaneous vaginal birth in the lying down group (number needed to treat 17, 95% confidence interval 11 to 40). No evidence of differences was found for most of the secondary maternal, neonatal, or longer term outcomes including instrumental vaginal delivery (adjusted risk ratio 1.08, 99% confidence interval 0.99 to 1.18), obstetric anal sphincter injury (1.27, 0.88 to 1.84), infant Apgar score <4 at five minutes (0.66, 0.06 to 6.88), and maternal faecal incontinence at one year (1.18, 0.61 to 2.28).Conclusions Evidence shows that lying down in the second stage of labour results in more spontaneous vaginal births in nulliparous women with epidural analgesia, with no apparent disadvantages in relation to short or longer term outcomes for mother or baby.Trial registration Current Controlled Trials ISRCTN35706297.

Project description:BackgroundAn important prerequisite for optimal healthcare is a secure, safe and comfortable environment. There is little research on how the physical design of birthing rooms affects labour, birth, childbirth experiences and birthing costs. This protocol outlines the design of a randomised controlled superiority trial (RCT) measuring and comparing effects and experiences of two types of birthing rooms, conducted in one labour ward in Sweden.Methods/designFollowing ethics approval, a study design was developed and tested for feasibility in a pilot study, which led to some important improvements for conducting the study. The main RCT started January 2019 and includes nulliparous women presenting to the labour ward in active, spontaneous labour and who understand either Swedish, Arabic, Somali or English. Those who consent are randomised on a 1:1 ratio to receive care either in a regular room (control group) or in a newly built birthing room designed with a person-centred approach and physical aspects (such as light, silencer, media installation offering programmed nature scenes with sound, bathtub, birth support tools) that are changeable according to a woman's wishes (intervention group). The primary efficacy endpoint is a composite score of four outcomes: no use of oxytocin for augmentation of labour; spontaneous vaginal births (i.e. no vaginal instrumental birth or caesarean section); normal postpartum blood loss (i.e. bleeding < 1000 ml); and a positive overall childbirth experience (7-10 on a scale of 1-10). To detect a difference in the composite score of 8% between the groups we need 1274 study participants (power of 80% with significance level 0.05). Secondary outcomes include: the four variables in the primary outcome; other physical outcomes of labour and birth; women's self-reported experiences (the birthing room, childbirth, fear of childbirth, health-related quality of life); and measurement of costs in relation to the hospital stay for mother and neonate. Additionally, an ethnographic study with participant observations will be conducted in both types of birthing rooms.DiscussionThe findings aim to guide the design of birthing rooms that contribute to optimal quality of hospital-based maternity care.Trial registrationClinicalTrials.gov NCT03948815. Registered 13 May 2019-retrospectively registered.

Project description:ObjectiveTo explore whether an ultrasound-guided pudendal nerve block (PNB) could decrease anaesthetic use, thereby shortening the length of the second stage of labour in women undergoing epidural analgesia.DesignProspective, single-centre, randomised, double-blind, controlled trial.SettingAn obstetric centre in a general hospital in China.Participants72 nulliparous women were randomised, and 71 women completed the study.InterventionAn ultrasound-guided bilateral PNB was administered to all study participants; the PNB group were given 0.25% ropivacaine 10 mL, while the control group were given 10 mL saline.Main outcome measureThe primary outcome measure was the duration of the second stage of labour. Secondary outcomes included additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30 min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain.ResultsThe duration of the second stage of labour was shorter in the PNB group than in the control group (difference of 33.8 min (95% CI 15.6 to 52.0), p<0.001). Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001). DRAM2 was greater (p<0.001), rate of parturient women with the urge to defecate was higher (p=0.014), maternal cooperation was superior (p=0.002), and lower limb motor function preservation was greater (p=0.004) in the PNB group relative to the control group. Tightness of the perineum was eliminated from the results due to the inconsistent application of the criteria by the nursing staff. There was no significant difference in NRS scores between the groups.ConclusionsNulliparous women with epidural analgesia who received an ultrasound-guided bilateral PNB may reduce their need for bupivacaine and consequently shorten the length of the second stage of labour, therein indicating that a bilateral PNB may serve as an additional effective adjunct method of labour analgesia.Trial registration numberChiCTR-IOR-16009121.

Project description:ObjectiveThis study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.Study designThis was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.ResultsIn total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.ConclusionPostcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.Key points· This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.. · Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.. · This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section..

Project description:BACKGROUND:Although breast milk has numerous benefits for infants' development, with greater effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support intervention after discharge from NICU is expected to promote mothers' sense of trust in their own capacity and thereby facilitate breastfeeding. METHODS/DESIGN:A multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. PRIMARY OUTCOME:proportion of mothers exclusively breastfeeding at eight weeks after discharge. SECONDARY OUTCOMES:proportion of breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff. DISCUSSION:This paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.

Project description:ObjectiveTo investigate whether a 20-mL buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.MethodsIn a randomized, single-blind, placebo-controlled trial, women were assigned to receive either a 20-mL buffered 1% lidocaine paracervical block or no block before IUD placement. The primary outcome was pain with IUD placement measured on a 100-mm visual analog scale. Our sample size had 80% power (α=0.05) to detect a 20-mm difference in visual analog scale scores with a SD of 28 mm. Secondary outcomes included pain with speculum placement, paracervical block administration, tenaculum placement, 5 minutes postprocedure, and overall pain perception.ResultsFrom October 7, 2014, through October 26, 2017, 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). There were no differences in baseline demographics between the groups. Women who received the paracervical block reported less pain with IUD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=.002). Pain was significantly less in the intervention group for uterine sounding (30 mm vs 47 mm, P=.005), 5 minutes after placement (12 mm vs 27 mm, P=.005), and overall pain perception (30 mm vs 51 mm, P=.015). Participants who received the paracervical block experienced more pain with block administration compared with placebo (30 mm vs 8 mm, P=.003). There was no perceived pain difference for speculum insertion (10 mm vs 6 mm, P=.447) or tenaculum placement (15 mm vs 10 mm, P=.268).ConclusionA 20-mL buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 minutes after placement (secondary outcome). Although paracervical block administration can be painful, perception of pain for overall IUD placement procedure is lower compared with no block.Clinical trial registrationClinicalTrials.gov, NCT02219308.

Project description:Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied.This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.

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Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial.

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Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial.

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