Vacuum-assisted DeliveriesNCT07534969
Fixed-Interval vs. On-Demand Analgesia After Vacuum-Assisted Delivery: RCT
A study testing Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours. and On demand analgesia in people with Vacuum-assisted Deliveries, run by Yael Yagur at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vacuum-assisted Deliveries
- What is being tested?
- Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours. and On demand analgesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Sep 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Allergy to acetaminophen or NSAIDs.
- Chronic pain conditions (e.g., endometriosis, fibromyalgia).
- Cesarean deliveries.
- Multiple pregnancies.
- Normal vaginal delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fixed-time Interval vs. On-demand Analgesia Following Vacuum-assisted Vaginal Delivery: A Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
Study Objectives:
- Primary Objective: 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).
- Secondary Objectives:
- Measure VAS scores every 8 hours during the first 24 hours postpartum.
- Assess the use of pain relief beyond 24 hours postpartum, including the use of morphine.
- Evaluate breastfeeding rates, satisfaction with the birth experience, and length of postpartum hospitalization.
Study Design:
- Recruitment: Women will be recruited immediately after vacuum-assisted delivery.
- Participants will provide informed consent and be assigned a unique anonymous identifier for data collection.
- All participants will receive 1,000 mg of IV acetaminophen immediately postpartum, per departmental protocol.
- Participants will be randomized (1:1) into two groups:
- Scheduled Pain Relief Group: Oral acetaminophen (1 g) and diclofenac (50 mg) every 8 hours for the first 24 hours postpartum.
- On-Demand Pain Relief Group: The same oral medications as the scheduled group but administered only upon request.
- After the first 24 hours postpartum, both groups will receive pain relief on-demand.
- Women experiencing breakthrough pain despite their assigned protocol will receive additional medication as needed, and such interventions will be recorded.
Pain Assessment:
Pain levels will be assessed using the VAS scale every 8 hours, and one hour before and after administering pain relief.
Data Collection:
- Demographics: Age, BMI, parity, gestational age at delivery.
- Delivery details:
- Mode of labor onset (spontaneous or induced).
- Cervical ripening method (prostaglandins or balloon).
- Use of oxytocin during labor.
- Duration of active and second stages of labor.
- Use of epidural anesthesia.
- Perineal tears (grades 1-4).
- Estimated and excessive blood loss.
- Placental separation (manual removal or uterine exploration).
- Neonatal weight.
- Outcomes:
- Pain scores (VAS)
- Medication use
- Breastfeeding rates
- Birth satisfaction (assessed via the validated Birth Satisfaction Scale-BSS-R).
Study Population:
- Inclusion Criteria: Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.
- Exclusion Criteria:
- Allergy to acetaminophen or NSAIDs.
- Chronic pain conditions (e.g., endometriosis, fibromyalgia).
- Cesarean deliveries.
- Multiple pregnancies.
Sample Size:
Based on prior studies, 100 women per group are required to detect a 33% reduction in VAS scores (from 6 ± 2 to 4 ± 2) with 80% power and a 5% significance level. A total of 200 participants will be recruited.
Duration:
The study will run for five years. Data will be securely stored for 15 years in a locked cabinet and password-protected computer accessible only to the principal investigator.
Statistical Analysis:
Data will be analyzed using SPSS software. ANOVA will be used to compare outcomes between groups.
This study addresses a gap in literature by investigating pain management protocols specifically for vacuum-assisted deliveries, aiming to improve postpartum care and maternal satisfaction.
- Conditions
- Vacuum-assisted Deliveries
- Being tested
- Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours., On demand analgesia
- Keywords
- vacuum-assisted deliveries, Pain managmant after vacuum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.Drug
Also called Scheduled
Oral acetaminophen (1 g) and diclofenac (50 mg) administered during the first 24 hours postpartum together every 8 houers
On demand analgesiaOther
Also called On demand
Administration of analgesics upon patient request
| Study group | Role | What they receive |
|---|---|---|
| Scheduled Pain Relief | Active comparator | Scheduled Pain Relief Receives: 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 Receives: Other: On demand analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment until discharge following delivery, up to 1 week.
Secondary outcomes (4)
Pain relif use, hospitalization, breastfeeding and maternal satisfaction.
group differences in VAS pain scores at predefined 8-hour intervals during the first 24 hours postpartum, use of additional analgesia beyond 24 hours postpartum, breastfeeding rates, length of postpartum hospitalization and maternal satisfaction.
Measured: From enrollment until discharge following delivery, up to 1 week.
Baseline maternal and obstetric characteristics
Maternal age (Years), body mass index (BMI), parity, and gestational age at delivery. (weeks)
Measured: From enrollment until discharge following delivery, up to 1 week.
Labor and delivery characteristics
mode of labor onset, cervical ripening method (prostaglandins, balloon catheter, or combined methods), use of oxytocin augmentation, epidural anesthesia, and indication for vacuum-assisted delivery (non-reassuring fetal heart rate, prolonged second stage, or maternal exhaustion)
Measured: From enrollment until discharge following delivery, up to 1 week.
Delivery outcomes and maternal complications
Episiotomy, degree of perineal lacerations (1-4 degree), postpartum hemorrhage, maternal fever, manual removal of the placenta, uterine revision, urinary retention, retained products of conception.
Measured: From enrollment until discharge following delivery, up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start21 Sep 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vacuum-assisted DeliveriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yael Yagur
- Sponsor type
- University, hospital or other
- Collaborators
- Meir Medical Center
- Responsible party
- Sponsor-investigator, Yael Yagur, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534969
- Sponsor's protocol ID
- 104-24MMC
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed-time Interval vs. On-demand Analgesia Following Vacuum-assisted Vaginal Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534969
- Acronym / sponsor ID
- 104-24MMC
- Conditions
- Vacuum-assisted Deliveries
- Keywords
- vacuum-assisted deliveries, Pain managmant after vacuum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yael YagurUniversity, hospital or other
- Collaborators
- Meir Medical Center
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives:
- Primary Objective: 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).
- Secondary Objectives:
- Measure VAS scores every 8 hours during the first 24 hours postpartum.
- Assess the use of pain relief beyond 24 hours postpartum, including the use of morphine.
- Evaluate breastfeeding rates, satisfaction with the birth experience, and length of postpartum hospitalization.
Study Design:
- Recruitment: Women will be recruited immediately after vacuum-assisted delivery.
- Participants will provide informed consent and be assigned a unique anonymous identifier for data collection.
- All participants will receive 1,000 mg of IV acetaminophen immediately postpartum, per departmental protocol.
- Participants will be randomized (1:1) into two groups:
- Scheduled Pain Relief Group: Oral acetaminophen (1 g) and diclofenac (50 mg) every 8 hours for the first 24 hours postpartum.
- On-Demand Pain Relief Group: The same oral medications as the scheduled group but administered only upon request.
- After the first 24 hours postpartum, both groups will receive pain relief on-demand.
- Women experiencing breakthrough pain despite their assigned protocol will receive additional medication as needed, and such interventions will be recorded.
Pain Assessment:
Pain levels will be assessed using the VAS scale every 8 hours, and one hour before and after administering pain relief.
Data Collection:
- Demographics: Age, BMI, parity, gestational age at delivery.
- Delivery details:
- Mode of labor onset (spontaneous or induced).
- Cervical ripening method (prostaglandins or balloon).
- Use of oxytocin during labor.
- Duration of active and second stages of labor.
- Use of epidural anesthesia.
- Perineal tears (grades 1-4).
- Estimated and excessive blood loss.
- Placental separation (manual removal or uterine exploration).
- Neonatal weight.
- Outcomes:
- Pain scores (VAS)
- Medication use
- Breastfeeding rates
- Birth satisfaction (assessed via the validated Birth Satisfaction Scale-BSS-R).
Study Population:
- Inclusion Criteria: Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.
- Exclusion Criteria:
- Allergy to acetaminophen or NSAIDs.
- Chronic pain conditions (e.g., endometriosis, fibromyalgia).
- Cesarean deliveries.
- Multiple pregnancies.
Sample Size:
Based on prior studies, 100 women per group are required to detect a 33% reduction in VAS scores (from 6 ± 2 to 4 ± 2) with 80% power and a 5% significance level. A total of 200 participants will be recruited.
Duration:
The study will run for five years. Data will be securely stored for 15 years in a locked cabinet and password-protected computer accessible only to the principal investigator.
Statistical Analysis:
Data will be analyzed using SPSS software. ANOVA will be used to compare outcomes between groups.
This study addresses a gap in literature by investigating pain management protocols specifically for vacuum-assisted deliveries, aiming to improve postpartum care and maternal satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Scheduled Pain Relief | Active comparator | Drug: Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.Scheduled Pain Relief |
| On-Demand Pain Relief Group | Placebo comparator | Other: On demand analgesiapain relief drug by request |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Allergy to acetaminophen or NSAIDs.
- Chronic pain conditions (e.g., endometriosis, fibromyalgia).
- Cesarean deliveries.
- Multiple pregnancies.
- Normal vaginal delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.Also: ScheduledOral acetaminophen (1 g) and diclofenac (50 mg) administered during the first 24 hours postpartum together every 8 houers | Drug | Scheduled Pain Relief |
| On demand analgesiaAlso: On demandAdministration of analgesics upon patient request | Other | On-Demand Pain Relief Group |
Primary outcome
Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum
Time frame: From enrollment until discharge following delivery, up to 1 week.
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).
4 secondary outcomes
Pain relif use, hospitalization, breastfeeding and maternal satisfaction.
Time frame: From enrollment until discharge following delivery, up to 1 week.
Baseline maternal and obstetric characteristics
Time frame: From enrollment until discharge following delivery, up to 1 week.
Labor and delivery characteristics
Time frame: From enrollment until discharge following delivery, up to 1 week.
Delivery outcomes and maternal complications
Time frame: From enrollment until discharge following delivery, up to 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Vacuum-assisted Deliveries
Active, not recruiting
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Pelvic Floor Disorders, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours. and On demand analgesia in people with Vacuum-assisted Deliveries, run by Yael Yagur at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum (time frame: From enrollment until discharge following delivery, up to 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.