The Antibiotics In Miscarriage Surgery (AIMS) trial
| ISRCTN | ISRCTN97143849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97143849 |
| Protocol serial number | RG_12-048 |
| Sponsor | University of Birmingham (UK) |
| Funders | Joint Global Health Trials Scheme, Medical Research Council (UK), grant ref: MR/J009792/1, Wellcome Trust (UK), grant ref: 099943, Department for International Development (DfID) (UK) |
- Submission date
- 26/03/2013
- Registration date
- 17/04/2013
- Last edited
- 14/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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. If antibiotics are given just before the procedure of miscarriage surgery this may reduce the chance of infection occurring. The aim of this study is to test this in four low income countries.
Who can participate?
Women who have suffered a miscarriage and are scheduled to have their miscarriage managed surgically, through an operation to empty their uterus.
What does the study involve?
Participants are offered either a single dose of prophylactic antibiotics (doxycycline and metronidazole) or an identical looking dummy pill (placebo), to be taken by mouth before the surgery. Participants are followed 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 are given full treatment as soon as it is detected. The study also assess whether 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 also facilitate these women receiving prompt treatment if there are any problems. Even if participants do not benefit personally they study may help improve 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 study is being managed and sponsored by the University of Birmingham (UK). The study sites are:
1. Malawi: Queen Elizabeth Central Hospital, Zomba Central Hospital and Kamuzu Central Hospital
2. Uganda: Mbale Regional Referral Hospital and Soroti Regional Referral Hospital
3. Tanzania: St Francis Hospital, Mwananyamala Hospital and Bagamoyo District Hospital
4. Pakistan: Aga Khan University Main Hospital, Hyderabad Hospital, Garden Hospital, Kharader Hospital and Karimabad Hospital
When is the study starting and how long is it expected to run for?
September 2013 to May 2017
Who is funding the study?
The Medical Research Council, the Wellcome Trust and the Department for International Development (UK)
Who is the main contact?
Dr David Lissauer
d.m.lissauer@bham.ac.uk
Contact information
Scientific
School of Clinical and Experimental Medicine
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Scientific
School of Clinical and Experimental Medicine
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled multi-national study with economic evaluation |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 acronym | AIMS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Infection, miscarriage, sepsis, antibiotic prophylaxis |
| Intervention | 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 Both the woman and health worker will not know which type of tablets they have been given. Participants are followed 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. The study will also determine whether using antibiotics before surgery is cost effective. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doxycycline, metronidazole |
| Primary outcome measure(s) |
Current primary outcome measures as of 27/01/2017: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 27/01/2017: |
| Completion date | 16/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 3400 |
| Total final enrolment | 3412 |
| Key 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 |
| Key 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 < 38oC) 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 |
| Date of first enrolment | 02/06/2014 |
| Date of final enrolment | 26/04/2017 |
Locations
Countries of recruitment
- Malawi
- Pakistan
- Tanzania
- Uganda
Study participating centres
Malawi
Malawi
Malawi
Uganda
Uganda
Tanzania
Tanzania
Tanzania
Pakistan
Pakistan
Pakistan
Pakistan
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/03/2019 | 14/03/2019 | Yes | No |
| Protocol article | protocol | 23/04/2018 | Yes | No | |
| Other publications | systematic review | 08/05/2018 | Yes | No | |
| Other publications | cost-effectiveness analysis | 01/09/2019 | 14/08/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/08/2019: Publication reference added.
21/03/2019: Publication reference added.
14/03/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the publication.
21/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2017 to 26/04/2017.
2. The overall trial end date was changed from 29/05/2017 to 16/05/2017.
26/04/2018: Publication reference added.
27/01/2017: The overall trial end date was changed from 01/03/2016 to 29/05/2017.
