Assess the use of Modified Perineal Protection Device in labour

Assessment of comparative efficacy of standard practice of labour with Modified perineal protection Device (MPPD) versus standard practice of labour alone in prevention perineal tear during second Stage of labour amongst Primi Parturient mothers:RCT - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072181

Enrollment

200

Registered

2024-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Modified perineal protection device (MPPD): Modified Perineal Protection Device (MPPD) will be used during second stage of labor process. Control Intervention1: Perineal support by peri

Eligibility

Inclusion criteria

Inclusion criteria: 1. Delivery with cephalic presentation 2. During Delivery Fully flexed Head 3. Birth Weight between 2.5 -3.5 kg 4. Age of mother between 18 -40 years 5. An understanding of both oral and written information in Hindi, Marathi and English.

Exclusion criteria

Exclusion criteria: 1. Mothers undergoing emergency caesarean section were excluded. 2. Mother with Breech presentation 3. Mother with high risk pregnancy (hypertension in pregnancy, Diabetes Mellitus , Cephalopelvic Disproportion etc) 4. Mother undergoing instrumental deliveries.(Forceps or Ventouse) 5. Mother participated in this type of study 6. Less than 32 weeks of gestation mother

Design outcomes

Primary

Measure	Time frame
Improvement of Maternal outcome in terms of perineal tear Timepoint: Assessment will be done immediately after delivery and at 6 weeks.	—

Secondary

Measure	Time frame
Maternal and neonatal Outcomes like Hemorrhage, Length of second stage of labour, Incidence of episiotomy, Status of perineal wound, Perineal pain, Sphincter function Urinary incontinence, faecal incontinenceTimepoint: Will be assessed at delivery and at 6 weeks after delivery	—

Countries

India

Contacts

Public ContactManjusha Mahakarkar

Datta Meghe Institute of Higher Education and Research

manjum4725@gmail.com9766565719

Outcome results