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Effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss- A Randomized Controlled Trial. -

SLCTR Registration Number

SLCTR/2017/014


Date of Registration

29 May 2017

The date of last modification

Jul 26, 2017



Application Summary


Scientific Title of Trial

Effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss- A Randomized Controlled Trial.


Public Title of Trial

A study on the effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete evacuation of uterus in women with early pregnancy loss


Disease of Health Condition(s) Studied

Miscarriage


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1195-1718


Any other number(s) assigned to the trial and issuing authority

J/ERC/16/76/DR/0036 (ERC: Jaffna)


Trial Details


What is the research question being addressed?

What is the effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

The study will be carried out at Teaching Hospital Jaffna.

Participants meeting the inclusion/exclusion criteria will be allocated to the study arms using simple randomization.

Arm 1 (intervention arm): Manual Vacuum Aspiration The procedure will be done under local anaesthesia (para cervical block) or sedation. Manual Vacuum Aspiration will be performed using a flexible cannula attached to a 60ml syringe (aspirator), with a double locking valve mechanism. at 12 hours post procedure participants will be offered ultrasound scan to assess the complete evacuation.

Arm 2 (control arm): Expectant care Participants will be educated regarding the expectant care and will be allowed to go home. Follow up will take place on day 7 and 14 with ultrasound scan to assess complete evacuation.

Standard of care: dilatation and curettage under general anaesthesia will be offered to both arms when the complete miscarriage not achieved.


Inclusion criteria

  1. A diagnosis of pregnancy loss will be made when Mean gestational sac diameter exceeds 20 mm in the absence of a yolk sac or embryo and absence of fetal cardiac activity as determined by observing the area of the fetal heart for at least 30 seconds

  2. Gestational age at 12 weeks or less

  3. Haemodynamically stable.

  4. Temperature not more than 37.5 degrees Celsius

  5. No history or concurrent acute medical or surgical condition.

  6. Legally married woman

  7. Not taking anticoagulants or corticosteroids

  8. Not on intrauterine device


Exclusion criteria

  1. Suspected ectopic pregnancy (on clinical and ultrasound examination)
  2. Pelvic infection
  3. Diagnosed bleeding disorders


Primary outcome(s)

Rate of complete miscarriage


Primary outcome(s) - Time of assessment(s)

At 12 hours post procedure in the manual vacuum aspiration arm

At Day 7 and 14 in the expectant care arm


Secondary outcome

1) Unplanned surgical evacuation

2) Patient satisfaction (assessed using a customized questionnaire)

3) Need for blood transfusion (haemoglobin level less than 8.0g/dl at the end of two weeks for expectant care and 12 hours after procedure for manual vacuum aspiration.)

4) Complications a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) b) Pelvic infection (temperature > 98.6 degrees Celcius; elevated white cell count (>11,000mm3); c- reactive protein >5) c) Reduction in the Haemoglobin level d) Uterine or cervical damage (By laparoscopy and vaginal examination)

5) Duration of hospital stay


Secondary outcome(s) - Time of assessment(s)

1) Unplanned surgical evacuation

2) Patient satisfaction (assessed using a customized questionnaire)

3) Need for blood transfusion (haemoglobin level less than 8.0g/dl at the end of two weeks for expectant care and 12 hours after procedure for manual vacuum aspiration.)

4) Complications a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) b) Pelvic infection (temperature > 98.6 degrees Celcius; elevated white cell count (>11,000mm3); c- reactive protein >5) c) Reduction in the Haemoglobin level d) Uterine or cervical damage (By laparoscopy and vaginal examination)

5) Duration of hospital stay



Target number/sample size

134 (67 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-05-30


Anticipated end date

2018-01-01


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Jaffnaon 16.1.2017 (Ref. No.: J/ERC/16/76/DR/0036)


Funding source

None (investigator funded)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. R.Sutharshan
Registrar in Obstetrics and Gynaecology
Teaching Hospital Jaffna, Hospital Street, Jaffna 40000 Sri Lanka
Tel: 021 222 2261
Mob: 0779232310

sutharshan11@gmail.com

Contact Person for Public Queries

Dr. K. Sureshkumar
Consultant Obstetrician and Gynaecologist
Teaching Hospital Jaffna, Hospital Street, Jaffna 40000 Sri Lanka

Mob: 0777256683.

vasuresh2003@yahoo.com


Primary study sponsor/organization

Teaching Hospital Jaffna

Hospital Street, Jaffna 40000 Sri Lanka
021 222 2261

thjaffna@gmail.com

Secondary study sponsor (If any)

None