title: A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol.
abstract: BACKGROUND
  Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour.
  
  
  METHODS
  We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort.
  
  
  CONCLUSIONS
  This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable beneficial effect, this gentle approach can be promoted as a replacement for the uncontrolled methods currently in use. If it is not found to be useful, fundal pressure can be discouraged.
authors.affiliation: Department of Obstetrics and Gynaecology at East London Hospital Complex (ELHC), Effective Care Research Unit (ECRU), and Eastern Cape Department of Health, University of the Witwatersrand, University of Fort Hare, East London, South Africa. justhof@gmail.com.
authors.forename: G Justus
authors.initials: GJ
authors.lastname: Hofmeyr
authors.affiliation: Department of Obstetrics and Gynaecology at East London Hospital Complex (ELHC), Effective Care Research Unit (ECRU), and Eastern Cape Department of Health, University of the Witwatersrand, University of Fort Hare, East London, South Africa. mandisa.singata@gmail.com.
authors.forename: Mandisa
authors.initials: M
authors.lastname: Singata
authors.affiliation: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland. tess@lawrie.com.
authors.forename: Theresa
authors.initials: T
authors.lastname: Lawrie
authors.affiliation: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland. vogeljo@who.int.
authors.forename: Joshua P
authors.initials: JP
authors.lastname: Vogel
authors.affiliation: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland. landoulsis@who.int.
authors.forename: Sihem
authors.initials: S
authors.lastname: Landoulsi
authors.affiliation: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland. seuca@who.int.
authors.forename: Armando H
authors.initials: AH
authors.lastname: Seuc
authors.affiliation: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland. gulmezoglum@who.int.
authors.forename: A Metin
authors.initials: AM
authors.lastname: Gülmezoglu
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D036861:Delivery, Obstetric / Q000379:methods*; D005260:Female; D006801:Humans; D007748:Labor Stage, Second / Q000502:physiology*; D010865:Pilot Projects; D011187:Posture / Q000502:physiology*; D011247:Pregnancy; D011312:Pressure; D012107:Research Design; D055815:Young Adult