Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears

NCT05851170 | Unknown DMC

• 1 other identifier: NHR-0198-22
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery. According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies. Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.

Conditions

Perineum; Tear

Keywords

Perineal tear; Warm compresses; Intact perineum; Almond oil

Outcome Measures

Primary Outcomes (1)

• Number of patients with perineal tear

  Perineal tear (spontaneous) that required suturing

  2 years

Secondary Outcomes (3)

• Number of patients with episiotomy

  2 years

• Number of patients with mild perineal tear

  2 years

• Number of patients with with advanced perineal tear

  2 years

Study Arms (2)

Use of warm compresses and almond oil use during the second stage

EXPERIMENTAL

Warm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care).

Other: The use of warm compresses and almond oil on the perineum during second stage

Use of almond oil use (routine care) during the second stage

ACTIVE COMPARATOR

During active pushing - almond oil will be applied on the perineum

Other: Use of almond oil use (routine care) during second stage

Interventions

The use of warm compresses and almond oil on the perineum during second stage OTHER

Hot water from the tap at a temperature of (45-590c) will be poured into a container, and will be changed every 15 minutes. Timing of the start: when the baby's head descends in the pelvic canal and the woman feels the need to push The intervention: warm compresses will be attached to the perineum between the pressures During the pressing - almond oil will be applied. Meanwhile, the compresses will be returned to a bowl containing hot water. Every 15 minutes until birth the water will be replaced with hot water at an initial temperature of 45-590c. It is necessary to use compresses for a minimum of 10 minutes, and a maximum of 30 minutes.

Also known as: Experimental

Use of warm compresses and almond oil use during the second stage

Use of almond oil use (routine care) during second stage OTHER

Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.

Also known as: Routine care

Use of almond oil use (routine care) during the second stage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancy
• Singleton pregnancy
• Vertex presentation

You may not qualify if:

• Women with a history of third degree perineal tear in the past
• Intrauterine fetal death
• Crohn disease with perineal involvement

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Northern District, Israel

RECRUITING

Related Publications (4)

• Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.

  PMID: 28608597 BACKGROUND

• Magoga G, Saccone G, Al-Kouatly HB, Dahlen G H, Thornton C, Akbarzadeh M, Ozcan T, Berghella V. Warm perineal compresses during the second stage of labor for reducing perineal trauma: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:93-98. doi: 10.1016/j.ejogrb.2019.06.011. Epub 2019 Jun 15.

  PMID: 31238205 BACKGROUND

• Pierce-Williams RAM, Saccone G, Berghella V. Hands-on versus hands-off techniques for the prevention of perineal trauma during vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2021 Mar;34(6):993-1001. doi: 10.1080/14767058.2019.1619686. Epub 2019 Jun 3.

  PMID: 31092083 BACKGROUND

• Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.

  PMID: 21614497 BACKGROUND

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Raneen Abu Shqara, MD

  Galilee Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raneen Abu Shqara, MD

CONTACT

+972549793591; rabushqara@gmail.com

Susana Mustafa, MD

CONTACT

+972502061625; mustafa.susana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, clinical instructor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: June 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

IL (1)