NCT07534969

Brief Summary

This randomized controlled trial evaluates the effectiveness of scheduled versus on-demand pain relief protocols in managing postpartum pain during the first 24 hours after vacuum-assisted delivery. Objectives: Primary: Compare pain reduction (VAS scores) between the two protocols. Secondary: Assess extended pain relief use, breastfeeding rates, maternal satisfaction, and postpartum hospitalization duration. Design: Participants: 200 women aged 18-45, randomized into two groups: Scheduled Pain Relief: Acetaminophen and diclofenac every 8 hours. On-Demand Pain Relief: Same medications administered upon request. Pain levels are assessed via VAS every 8 hours and around medication times. All participants receive IV acetaminophen immediately postpartum and additional pain relief for breakthrough pain as needed. Data Collection: Demographics, delivery details, pain scores, medication use, breastfeeding rates, and satisfaction (using the Birth Satisfaction Scale-BSS-R) will be recorded. Significance: The study aims to fill a gap in the literature on postpartum pain management for vacuum-assisted deliveries, improving care and maternal outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

December 1, 2024

Last Update Submit

April 11, 2026

Conditions

Vacuum-assisted Deliveries

Keywords

vacuum-assisted deliveriesPain managmant after vacuum

Outcome Measures

Primary Outcomes (1)

  • Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum

    Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).

    From enrollment until discharge following delivery, up to 1 week.

Secondary Outcomes (4)

  • Pain relif use, hospitalization, breastfeeding and maternal satisfaction.

    From enrollment until discharge following delivery, up to 1 week.

  • Baseline maternal and obstetric characteristics

    From enrollment until discharge following delivery, up to 1 week.

  • Labor and delivery characteristics

    From enrollment until discharge following delivery, up to 1 week.

  • Delivery outcomes and maternal complications

    From enrollment until discharge following delivery, up to 1 week.

Study Arms (2)

Scheduled Pain Relief

ACTIVE COMPARATOR

Scheduled Pain Relief

Drug: Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.

On-Demand Pain Relief Group

PLACEBO COMPARATOR

pain relief drug by request

Other: On demand analgesia

Interventions

Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.DRUG

Oral acetaminophen (1 g) and diclofenac (50 mg) administered during the first 24 hours postpartum together every 8 houers

Also known as: Scheduled
Scheduled Pain Relief
On demand analgesiaOTHER

Administration of analgesics upon patient request

Also known as: On demand
On-Demand Pain Relief Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Allergy to acetaminophen or NSAIDs.
  • Chronic pain conditions (e.g., endometriosis, fibromyalgia).
  • Cesarean deliveries.
  • Multiple pregnancies.
  • Normal vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 4861027, Israel

Location

MeSH Terms

Interventions

Appointments and SchedulesAbortion, Legal

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services AdministrationAbortion, InducedObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Yael Yagur

Study Record Dates

First Submitted

December 1, 2024

First Posted

April 16, 2026

Study Start

September 21, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)