Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162312
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-12-01
Brief Title:
Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
Official Title:
Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized controlled trial was undertaken at Rajavithi Hospital Bangkok Thailand encompassing 106 primigravidae within the period of December 2023 to June 2024 The intervention group underwent antepartum perineal massage starting at the 34th - 35th week of gestation and extending until delivery while the control group did not receive such intervention The primary outcome evaluated was the incidence of anal incontinence at the 3-month postpartum Secondary outcomes included the duration of each labor stage perineal tears and their degrees episiotomy occurrences Apgar scores at 1 and 5 minutes postpartum pain within 24 hours dyspareunia and urinary incontinence at the 3-month postpartum
Detailed Description:
Vaginal births often result in perineal trauma leading to substantial morbidity This study hypothesized that antenatal perineal massage APM could mitigate the incidence of perineal injuries and related postpartum morbidities
Participants at 34-35 weeks of gestation were randomly assigned by a computer program to either the Antenatal Perineal Massage APM group or the control group The APM group received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery while the control group did not receive such intervention
The technique involved inserting the thumb finger 3-5 cm into the vagina using a water-based jelly for lubrication The procedure included maintaining the thumb steady on the perineum for 1 minute applying up-and-down pressure for 1 minute and performing downward and sideways sweeping motions for 3 minutes Initial massage sessions were conducted under supervision at the antenatal clinic
Participants were advised to discontinue APM in case of premature rupture of membranes PROM bleeding or infection seeking prompt hospital management Additionally they were instructed to maintain a diary documenting their daily APM sessions
Both groups received standard antenatal intrapartum and postpartum care Obstetric care providers investigator and outcomes assessor remained blinded to participants study group allocations
During labor at the casualty department routine care was administered without intervention in labor management or cesarean delivery decisions Recorded data encompassed the duration of each labor stage perineal tears and their degrees episiotomy occurrences urgency for cesarean section or operative vaginal delivery infant weight sex Apgar scores at 1 and 5 minutes and postpartum pain using a verbal numerical rating scale within 24 hours
Participants were followed up at 3 months post-delivery to evaluate the anal incontinence urinary incontinence assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 PFDI-20 and dyspareunia using a verbal numerical rating scale
Participants at 34-35 weeks of gestation were randomly assigned by a computer program to either the Antenatal Perineal Massage APM group or the control group The APM group received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery while the control group did not receive such intervention
The technique involved inserting the thumb finger 3-5 cm into the vagina using a water-based jelly for lubrication The procedure included maintaining the thumb steady on the perineum for 1 minute applying up-and-down pressure for 1 minute and performing downward and sideways sweeping motions for 3 minutes Initial massage sessions were conducted under supervision at the antenatal clinic
Participants were advised to discontinue APM in case of premature rupture of membranes PROM bleeding or infection seeking prompt hospital management Additionally they were instructed to maintain a diary documenting their daily APM sessions
Both groups received standard antenatal intrapartum and postpartum care Obstetric care providers investigator and outcomes assessor remained blinded to participants study group allocations
During labor at the casualty department routine care was administered without intervention in labor management or cesarean delivery decisions Recorded data encompassed the duration of each labor stage perineal tears and their degrees episiotomy occurrences urgency for cesarean section or operative vaginal delivery infant weight sex Apgar scores at 1 and 5 minutes and postpartum pain using a verbal numerical rating scale within 24 hours
Participants were followed up at 3 months post-delivery to evaluate the anal incontinence urinary incontinence assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 PFDI-20 and dyspareunia using a verbal numerical rating scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None