Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Infection following miscarriage surgery is a problem affecting over 33 million pregnancies each year. A majority of women will have their miscarriage managed with surgery to empty the womb. Infection can occur following this surgery and this is a particular problem in low income countries. In some low income countries the rates of infection following miscarriage surgery are as high as 30%. These infections can result in death, serious illness or long-term health problems. Currently international and national medical guidelines do not recommend antibiotics to be given routinely in miscarriage surgery, because there is no evidence that tells us that this works. We propose that if antibiotics are given just before the procedure of miscarriage surgery this may reduce the chance of infection occurring. We will test this with a large study conducted in four low income countries.

Who can participate?
This study will recruit women who have suffered a miscarriage and are scheduled to have their miscarriage managed surgically, through an operation to empty their uterus. 3400 women will be recruited from study sites in Malawi, Uganda, Tanzania and Pakistan.

What does the study involve?
If consent is given, women will be offered either a single dose of prophylactic antibiotics (400mg doxycycline and 400mg metronidazole) or an identical looking dummy pill (placebo), to be taken by mouth before the surgery. Both the woman and health worker will not know which type of tablets they have been given. We will carefully follow participants for 2 weeks after surgery to see if there is any difference in the rate of women developing pelvic infection. If any women show signs of infection they will be given full treatment as soon as it is detected. We will also see if using antibiotics before surgery is cost effective.

What are the possible benefits and risks of participating?
Those women taking part in the study may benefit by having their health followed very carefully after the surgery. The study team will also facilitate these women receiving prompt treatment if there are any problems. Even if participants do not benefit personally they will have taken part in a study that may help improve the care for women in the future. Risks of taking part include the small risk of side-effects from doxycycline or metronidazole, but these medications have been selected because they have a low risk of serious side-effects such as allergy.

Where is the study run from?
The trial is being managed and sponsored by the University of Birmingham, United Kingdom.
The study sites are in Malawi, Uganda, Tanzania and Pakistan.

When is the study starting and how long is it expected to run for?
The trial is due to start recruiting in September 2013, and will continue to recruit for 2 years.

Who is funding the study?
This is being funded by the Medical Research Council, the Wellcome Trust and the Department for International Development, United Kingdom.

Who is the main contact?
Dr David Lissauer

Trial website

Contact information



Primary contact

Prof Arri Coomarasamy


Contact details

School of Clinical and Experimental Medicine
University of Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness of antibiotic prophylaxis during surgical evacuation of the uterus for miscarriage management in low income countries: a multinational, randomised, double-blind placebo-controlled trial



Study hypothesis

To test the hypothesis that in women having miscarriage surgery, pre-surgery prophylactic antibiotics (oral doxycycline 400 mg and oral metronidazole 400 mg) reduces the risk of pelvic infection within 14 days of surgery.

Ethics approval

1. UK - Liverpool Ethics, 10/04/2013, protocol 13.15
2. Malawi - College of Medicine Research Ethics Committee, 11/10/2013, P.06/13/1393
3. Pakistan - Aga Khan University Research Ethics Committee, 11/11/2013, 2756-obs-erc-13
4. Pakistan - Drugs Regulatory Authority of Pakistan, 16/09/2014, F.6-1/2013
5. Tanzania - IHI IRB, 30/08/2013, IHI/IRB/no.25-2013
6. Tanzania - NIMRI, 01/11/2013, NIMRlHQ/R.8aJVol. IX/1652
7. Tanzania - TDFA, 04/08/2014, TFDAI4/CTR/001/03
8. Uganda - UNCST, 28/05/2014, HS 1400
9. Uganda - NDA, 06/12/2013, 347/ESR/NDA/DID-06/2013

Study design

Randomised double-blind placebo-controlled multi-national study with economic evaluation

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Infection, miscarriage, sepsis, antibiotic prophylaxis


1. Doxycycline 400 mg oral and Metronidazole 400 mg oral, taken approximately 2 hours before the scheduled time of surgery.
2. Placebo tablets of identical appearance and weight.

Intervention type



Not Applicable

Drug names

Doxycycline, metronidazole

Primary outcome measures

Pelvic infection within 14 days of surgery, defined as two or more of a) purulent vaginal discharge, b) pyrexia >38.0°C, c) uterine tenderness on examination and d) a white cell count >15x10^9 /l, with no other recognised cause of infection.

Secondary outcome measures

1. Secondary measures:
Death, hospital admission, unplanned consultations, antibiotic use for presumed diagnosis of pelvic infection, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms (pain, additional analgesia, vaginal bleeding, days before return to usual daily activities).
2. Outcomes for exploratory analyses: Surgical complications. Full microbiological information, antibiotic sensitivities and any evidence of drug resistance will be collected where available.
3. Resource use outcomes: The main resources to be monitored include: Additional staff time for explanation and dispensing of the medication, type and grade of the health professional caring for each woman, inpatient admissions and consultations (planned and unplanned), outpatient and emergency admissions and consultations, unplanned further surgical interventions (e.g. curettage), additional investigation costs (e.g. ultrasounds), consumables (e.g. medication), resources used to manage surgery and treatment related complications (e.g. bleeding requiring transfusion).

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Women with a spontaneous miscarriage (under 22 weeks gestation)
2. Women undergoing surgical evacuation of the uterus (by manual vacuum aspiration, suction curettage or sharp curettage)
3. Willing and able to give informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Induced abortion of pregnancy
2. Septic miscarriage or evidence of infection
3. Allergy to either of the antibiotics
4. Current antibiotic use, or antibiotic use in the 7 days preceding surgical evacuation
5. Current febrile illness (temperature < 380c
7. Other contraindication to doxycycline or metronidazole use
8. Patient with condition requiring immediate care e.g. severe haemorrhage
9. Age less than 16 years

Recruitment start date


Recruitment end date



Countries of recruitment

Malawi, Pakistan, Tanzania, Uganda

Trial participating centre

University of Birmingham
B15 2TT
United Kingdom

Sponsor information


University of Birmingham (UK)

Sponsor details

Sean Jennings
Research Governance and Ethics Manager
Research Support Group
Room 119
Aston Webb Building
University of Birmingham
B15 2TT
United Kingdom

Sponsor type




Funder type


Funder name

Joint Global Health Trials Scheme

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Medical Research Council (UK), grant ref: MR/J009792/1

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Funder name

Wellcome Trust (UK), grant ref: 099943

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Funder name

Department for International Development (DfID) (UK)

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes