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Surgical, medical or expectant management of first trimester miscarriage and its implications on clinical and psychological outcomes - a Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2014/029

Date of Registration

23 Oct 2014

The date of last modification

Mar 03, 2019

Trial Status


Application Summary

Scientific Title of Trial

Surgical, medical or expectant management of first trimester miscarriage and its implications on clinical and psychological outcomes - a Randomized Controlled Trial

Public Title of Trial

A study to compare various treatment methods for the miscarriage during the first fourteen weeks of pregnancy

Disease or Health Condition(s) Studied

First trimester miscarriage

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

None

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

EC-13-183 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)


Trial Details

What is the research question being addressed?

What are the clinical and psychological outcomes of surgical management compared to medical management or expectant management of first trimester miscarriage?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Active

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Applicable

Intervention(s) planned

Consenting participants will be randomized into three arms using computer generated random numbers.

Arm 1 (Surgical Management): Surgical management will be by vacuum aspiration under general anesthesia. Pain relief, Rh immunization and provision of advice or information regarding other aspects of care and recovery will be provided according to usual hospital procedure.

Arm 2 (Medical Management) Four200microgram tablets [800micg] of misoprostol [MISOPROST- 200 micg, CIPLA, INDIA] will be inserted into the posterior fornix of the vagina, with a repeat dose of 800 micg 4-6 hours later if the miscarriage is still incomplete.

Arm 3 (Expectant Management) Women receiving expectant care will be given a contact phone number to use if unsure or anxious and an information sheet with details of expected symptoms or signs and indications that further care is required. They will be discharged on day 2. Participants in the expectant care group will be advised to seek admission if they develop severe bleeding or fever.

Inclusion criteria

  1. Gestational age less than 14 weeks POA
  2. Bleeding not excessive (Excessive bleeding: soaking through one or more pads every hour for several consecutive hours)
  3. Haemodynamically stable
  4. Temperature not more than 37.5 degrees Celsius
  5. No history of current serious systemic medical or surgical condition
  6. Use of prostaglandins not contraindicated (including no known allergies)
  7. 18 years or older
  8. Not taking anticoagulants or corticosteroids
  9. Singleton pregnancy
  10. No intrauterine device in situ.
  11. Sufficient familiarity with Sinhala or Tamil to complete written questionnaires

Exclusion criteria

  1. Complete miscarriage
  2. Sepsis.

Primary outcome(s)

1.

Rate of complete miscarriage (defined as an empty uterus or homogenous intra uterine dimension measuring less than 11 cm2 [sagittal plus trans-vaginal plane] on trans-vaginal ultrasound examination).

 [

At day 14 of following the intervention

]

Secondary outcome(s)

1.
  1. Unplanned surgical intervention [a second evacuation in the surgical group but a first evacuation in the medical or expectant group]
  2. Blood transfusion
  3. Hemorrhage [blood loss greater than 500ml]
  4. Anaemia [reduction of equal or more than 2g/dl from the Hb level on admission]
  5. Days of bleeding
  6. Pain relief [Type, dose and duration of NSAIDs]
  7. Pelvic infection
  8. Cervical damage/Uterine perforation
  9. Digestive disorders [nausea/vomiting/ diarrhoea]
  10. Duration of stay in hospital
  11. Psychological effects [assessed by GHQ-12]
  12. Women’s views/ acceptability of method
 [

At Day 7, Day 14, and Day 28 following the intervention

]

Target number/sample size

180

Countries of recruitment

Sri Lanka

Anticipated start date

2014-11-05

Anticipated end date

2015-05-05

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals

MTS/CP/P14/CT/03/2014


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-02-20

Approval number

EC-13-185

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. M. Kopalakrishnan
Registrar, Professorial Unit
De Soysa Maternity Hospital For Women Colombo

Tel: 0773136632

kopalakrishnan14@yahoo.com

Contact Person for Public Queries

Prof. Athula Kaluarachchi
Professor, Department of Obstetrics & Gynaecology
Faculty of Medicine, University of Colombo, Srilanka
Tel: (094)112695300
Tel: 0714765180

athula_kal@yahoo.com

Primary study sponsor/organization

De Soysa Hospital for Women

Colombo 8, Sri Lanka
Tel: 0112662619-23
Fax: 0112697315

http://www.dmh.health.gov.lk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Yes

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options