Vacuum Delivery in All-fours Position vs Traditional Position

NCT05612321 | Unknown FDA Device

• 1 other identifier: VaDe-4/2022
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor. The main question it aims to answer are:

• Does the rate of failure of vacuum delivery, measured as number of cup detachments and the need of emergency caesarean section is lower if vacuum delivery is performed on a woman in all-fours position?
• Do maternal and fetal outcomes are better in case vacuum delivery in all-fours position? Participants will be randomly enrolled at the admission in two different groups, Control and Experimental Group, and in case of need for vacuum-assisted vaginal delivery; women belonging to Control Group will undergo vacuum-assisted delivery in traditional supine position, while women in Experimental Group will experience vacuum application in all-fours position. Researchers will compare the Group A, composed by women who undergo vacuum-delivery in traditional supine position, with Group B, in which women are in "all-fours" position, to see if hands-and-knees position provides better outcomes.

Conditions

Prolonged Second Stage of Labor; Prolonged Second Stage of Labor Due to Poor Maternal Effort

Keywords

Vacuum-assisted vaginal delivery; All-fours position; Arrest of descent; Operative vaginal delivery

Outcome Measures

Primary Outcomes (2)

• Vacuum detachments

  Vacuum detachments (Yes/No)

  Day 0

• Rate of Emergency C-Section

  Emergency C-section (Yes/No)

  Day 0

Secondary Outcomes (17)

• Perineal tears

  Day 1

• Obstetric anal sphincter injuries (OASIS)

  Day 1

• Episiotomy

  Day 1

• Blood loss

  Day 1

• Postpartum haemorrhage

  Day 1

Study Arms (2)

Traditional supine position

ACTIVE COMPARATOR

Participants enrolled in the Control Group undergo vacuum-assisted delivery in traditional supine position (supine with 90 degrees bended legs on footrests)

Device: Vacuum application

All-fours position

EXPERIMENTAL

Participants enrolled in Experimental Group experience vacuum application in all-fours position.

Device: Vacuum application

Interventions

Vacuum application DEVICE

vacuum-assisted delivery

All-fours position; Traditional supine position

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This study requires the enrollement of only female participants as it refers to delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women
• singleton
• cephalic presentation
• term pregnancy
• second stage of labor
• failure to progress
• maternal weariness
• need for operative vaginal delivery by vacuum extraction

You may not qualify if:

• enrollment refusal
• absence of consent
• contraindication to operative vaginal delivery

Sponsors & Collaborators

• Ospedale degli Infermi di Biella: lead

Related Publications (14)

• Merriam AA, Ananth CV, Wright JD, Siddiq Z, D'Alton ME, Friedman AM. Trends in operative vaginal delivery, 2005-2013: a population-based study. BJOG. 2017 Aug;124(9):1365-1372. doi: 10.1111/1471-0528.14553. Epub 2017 Feb 25.

  PMID: 28236337 RESULT

• Spencer C, Murphy D, Bewley S. Caesarean delivery in the second stage of labour. BMJ. 2006 Sep 23;333(7569):613-4. doi: 10.1136/bmj.38971.466979.DE. No abstract available.

  PMID: 16990297 RESULT

• Guo C, Ma W, Fan D, Ma Y, Liu L. Non spontaneous vaginal delivery was associated with lower probability of subsequent fertility. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:30-36. doi: 10.1016/j.ejogrb.2020.03.009. Epub 2020 Mar 7.

  PMID: 32172023 RESULT

• Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.

  PMID: 32217976 RESULT

• RANZCOG. The Women's Health Committee. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Instrumental vaginal birth; March 2016.

  RESULT

• Hobson S, Cassell K, Windrim R, Cargill Y. No. 381-Assisted Vaginal Birth. J Obstet Gynaecol Can. 2019 Jun;41(6):870-882. doi: 10.1016/j.jogc.2018.10.020.

  PMID: 31126436 RESULT

• Murphy DJ, Strachan BK, Bahl R; Royal College of Obstetricians and Gynaecologists. Assisted Vaginal Birth: Green-top Guideline No. 26. BJOG. 2020 Aug;127(9):e70-e112. doi: 10.1111/1471-0528.16092. Epub 2020 Apr 28. No abstract available.

  PMID: 32346983 RESULT

• Stremler R, Hodnett E, Petryshen P, Stevens B, Weston J, Willan AR. Randomized controlled trial of hands-and-knees positioning for occipitoposterior position in labor. Birth. 2005 Dec;32(4):243-51. doi: 10.1111/j.0730-7659.2005.00382.x.

  PMID: 16336365 RESULT

• Siccardi M, Valle C, Di Matteo F. Dynamic External Pelvimetry Test in Third Trimester Pregnant Women: Shifting Positions Affect Pelvic Biomechanics and Create More Room in Obstetric Diameters. Cureus. 2021 Mar 1;13(3):e13631. doi: 10.7759/cureus.13631.

  PMID: 33816030 RESULT

• Michel SC, Rake A, Treiber K, Seifert B, Chaoui R, Huch R, Marincek B, Kubik-Huch RA. MR obstetric pelvimetry: effect of birthing position on pelvic bony dimensions. AJR Am J Roentgenol. 2002 Oct;179(4):1063-7. doi: 10.2214/ajr.179.4.1791063.

  PMID: 12239066 RESULT

• Hemmerich A, Bandrowska T, Dumas GA. The effects of squatting while pregnant on pelvic dimensions: A computational simulation to understand childbirth. J Biomech. 2019 Apr 18;87:64-74. doi: 10.1016/j.jbiomech.2019.02.017. Epub 2019 Feb 27.

  PMID: 30851977 RESULT

• Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.

  PMID: 28414983 RESULT

• Bothou A, Apostolidi DM, Tsikouras P, Iatrakis G, Sarella A, Iatrakis D, Peitsidis P, Gerente A, Anthoulaki X, Nikolettos N, Zervoudis S. Overview of techniques to manage shoulder dystocia during vaginal birth. Eur J Midwifery. 2021 Oct 20;5:48. doi: 10.18332/ejm/142097. eCollection 2021.

  PMID: 34723155 RESULT

• Masturzo B, Delogu G, Germano C, Ghi T, Rizzo G, Puppo A, Attini R, Revelli A, Manzoni P. Vacuum delivery in all-fours position: is it a valuable, brand-new option? Am J Obstet Gynecol MFM. 2022 Nov;4(6):100691. doi: 10.1016/j.ajogmf.2022.100691. Epub 2022 Jul 16.

  PMID: 35843544 RESULT

MeSH Terms

Conditions

Cephalopelvic Disproportion

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bianca Masturzo, Md, PhD

  Ospedale degli Infermi di Biella

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Masturzo, MD PhD

CONTACT

+39 01515157001; bianca.masturzo@aslbi.piemonte.it

Chiara Germano, MD

CONTACT

+39 01515157002; chiara.germano@aslbi.piemonte.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Gynaecology and Obstetrics

Model Details: Multicentre, prospective, randomized open trial

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 10, 2022
• Study Start: December 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the end of the study, for 6 months from the 1st Jan 2024 to 1st July 2024
• Access Criteria: Participants centers