Home » Trials » SLCTR/2017/023


Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka. -

SLCTR Registration Number

SLCTR/2017/023


Date of Registration

18 Jul 2017

The date of last modification

Jul 18, 2017



Application Summary


Scientific Title of Trial

Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.


Public Title of Trial

Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.


Disease of Health Condition(s) Studied

Miscarriage


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1198-2573


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

EC-17-037 (ERC: Colombo)


Trial Details


What is the research question being addressed?

Is vacuum aspiration a safe and effective method when compared to curettage method, in managing patients with first trimester miscarriage in a limited resource setting in Sri Lanka ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

The study will be conducted at Ward 17, De Zoysa Maternity Hospital, Colombo 8, Sri Lanka.

Simple randomization will be used to allocate eligible participants to the study arms.

The intervention arm will receive vacuum aspiration of the retained products of conception. Suction evacuation will be done using a manual vacuum aspirator under analgesic cover without using anaesthesia, as an in-ward procedure. Efforts will be taken to avoid the usage of Hegar’s dilators.

The control arm will receive curettage of the retained products of conception. Surgical evacuation will be done using metal curette under general anesthesia in the Operation Theater. Hegar’s dilators will be used to dilate the cervix.

Standard monitoring and supportive care including uterotonics, antibiotics, anti-D immunoglobulin and blood transfusion will be provided to both arms based on standard guidelines. Ultra sound guided surgical evacuation under general anaesthesia will be provided if complete evacuation is not achieved. The data analysts will be blinded to the intervention status.


Inclusion criteria

  1. Diagnosis of miscarriage of less than 13 weeks POA (period of amenorrhea)
  2. No documented febrile illness
  3. Haemodynamically stable patients without any acute medical or surgical problems

Exclusion criteria

  1. Patients with features suggestive of septic miscarriage
  2. Patients who have the history of bleeding disorders/ anticoagulant therapy
  3. Patients found to have molar pregnancies
  4. Patients who are not willing to participate in the study
  5. Patients with suspected ectopic pregnancy


Primary outcome(s)

  1. Estimated blood loss and need for blood transfusion - using visual estimation of the number of soaked towels or sanitary pads and amount of blood clots in kidney tray, and haemoglobin concentration 24 hours post-procedure.

  2. Need for repeated evacuation (endometrial thickening more than 10mm on ultra sound scan of the abdomen at 12 hours post-procedure)

  3. Post-operative pain using a visual pain analogue scale.

  4. Cervical trauma (on visualization of the cervix post-procedure)

  5. Duration of procedure (in minutes)

  6. Duration of hospital stay


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

  1. Estimated blood loss and need of blood transfusion – immediately post procedure, and at the end of 24 hours.

  2. Need of repeated evacuation – 12 hours post procedure

  3. Post-operative pain – 6 hours post procedure

  4. Cervical trauma – immediately post procedure

  5. Duration of procedure – at the end of the procedure.

  6. Duration of hospital stay – at discharge


Secondary outcome

None


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

None



Target number/sample size

136 (68 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-07-24


Anticipated end date

2018-07-24


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo (Ref No: EC-17-037)


Funding source

None (Investigator funded)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. E. Ethayarooban
Registrar in Obstetrics and Gynaecology
Post Graduate Institute of Medicine Colombo 7, Sri Lanka

Mob: 0714289878 / 0776257989

roobanethayan@gmail.com

Contact Person for Public Queries

Dr. (Mrs) P. GowrySenthilnathan
Consultant Obstetrician and Gynaecologist
De Soysa Hospital for Women Colombo 08 Sri Lanka
Tel: 0112726775
Mob: 0777873244

gowrysenthilnathan@yahoo.com


Primary study sponsor/organization

De Zoysa Hospital for Women

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

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

Secondary study sponsor (If any)

None