Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03257514

Collaborator

(none)

102

Enrollment

Location

Arms

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Dehiscence Cesarean Scar Niche	Drug: alpha lipoic acid drug (thioctic acid acid) Drug: Placebo Oral Tablet	Phase 2

Detailed Description

This is a triple blind randomized placebo controlled prospective clinical trial that will be conducted in Ain Shams University Maternity Hospital.

in which a consecutive series of participant attending emergency room 102 women undergoing cesarean section for the first time will be randomized into two groups.

Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: alpha lipoic acid 51 women will receive alpha lipoic acid drug (thiotacid film coated tablets 600 mg) for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography (by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)	Drug: alpha lipoic acid drug (thioctic acid acid) Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.
Placebo Comparator: placebo 51 women will receive a placebo drug for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography(by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)	Drug: Placebo Oral Tablet placebo oral drug have the same shape of thiotacid tablet

Arm

Intervention/Treatment

Active Comparator: alpha lipoic acid

51 women will receive alpha lipoic acid drug (thiotacid film coated tablets 600 mg) for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography (by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)

Drug: alpha lipoic acid drug (thioctic acid acid)

Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.

Placebo Comparator: placebo

51 women will receive a placebo drug for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography(by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)

Drug: Placebo Oral Tablet

placebo oral drug have the same shape of thiotacid tablet

Outcome Measures

Primary Outcome Measures

presence of scar niche [six weeks after CS]
triangular shaped anechoic area at the site of incision
The healing ratio [six weeks after CS]
the thickness of residual myometrium covering the defect divided by the sum of the thickness of residual myometrium cover the defect and the height of wedge shaped defect

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Term pregnancy (gestational age between 37-41 weeks).
Women undergoing cesarean section for the first time.
Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
Uncomplicated cesarean section.
Lower uterine segment cesarean sections while the women not in labor.

Exclusion Criteria:

Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
Women who will use intrauterine device as a contraceptive method
Women with uterine abnormality as cervical stenosis or fibroid uterus
Women with pelvic infection at the time of saline sonohysterography

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo	Abbassia	Egypt	02002

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radwa Rasheedy Ali, lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03257514

Other Study ID Numbers:

maternity hospital ASU

First Posted:

Aug 22, 2017

Last Update Posted:

Mar 8, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thioctic Acid

Study Results

No Results Posted as of Mar 8, 2018