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The effect of Olea ointment and Lidocaine Gel 2 % on pain relieving and episiotomy wound healing

Comparison of Olea ointment and 2 % Lidocaine Gel on pain relieving and episiotomy wound healing in primiparous women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017020332374N1
Enrollment
123
Registered
2017-10-05
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Episiotomy. First degree perineal laceration during delivery,Second degree perineal laceration during delivery

Interventions

Intervention 1: Olea Ointment (First intervention group): This ointment is made in Farateb Company, Yazd,Iran. Its ingredients are:10 g Olive Oil, 10g Sesame, and 10 g honey.This ointment is available
Treatment - Drugs
Olea Ointment (First intervention group): This ointment is made in Farateb Company, Yazd,Iran. Its ingredients are:10 g Olive Oil, 10g Sesame, and 10 g honey.This ointment is available in 30 gram tube
Lidocaine gel 2% (Second intervention Group) is made in Razi Drug Company, Tehran, Iran. Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the interven
Normal Saline 0.9 % (Control Group), non-injectable, made in Parsdaro Co, Tehran,Iran. The Control group will only use Normal Saline twice a day till 10th day after childbirth.

Sponsors

Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criterias: Iranian patients; Primiparous; 18-35 years old; Literate; Volunteer; Term pregnancy with single fetus; Cephalic presentation; Mediolateral episiotomy; Newborn weight about 2500-4000 g; Absence of diseases affecting wound healing; Lack of PROM longer than 18 hours; The maternal BMI range between 19/8 and 30. Exclusion criteria: Unwillingness to continue to participate in the study; The use of other effective drugs for wound healing during the study; Inappropriate use of medications (more than two nights); Allergy to the Olea ointment or Lidocaine gel 2%; Failure to go to hospital on days 5 and 10 after delivery; Having a sexual relationship in the first five days after childbirth.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of episiotomy pain. Timepoint: Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum. Method of measurement: pain visual scale.;Episiotomy wound healing. Timepoint: Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum. Method of measurement: REEDA Scale.

Secondary

MeasureTime frame
Drug side effects. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Drug side effects Form.;Maternal health condition. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Maternal health condition Form.;Used analgesic. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Used analgesic Form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. FATEMEH JAFARZADEH-KENARSARI

GUILAN UNIVERSITY OF MEDICAL SCIENCES

f.kenarsari2013@gmail.com+98 13 4256 5058

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026