Condition category
Pregnancy and Childbirth
Date applied
05/05/2013
Date assigned
09/09/2013
Last edited
24/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The decrease of maternal death is one of the millennium goals defined by the World Health Organisation (WHO). Bleeding after delivery (postpartum hemorrhage) is the first cause of maternal death in countries with low incomes, and in particular in sub-Saharan African countries. Intrauterine tamponade with a condom catheter is a possible treatment for postpartum hemorrhage in these countries. The objective of this study is to demonstrate that the intrauterine tamponade by condom catheter reduces death and severe disease rates in cases of severe postpartum hemorrhage.

Who can participate?
All women giving birth in one of the centers participating in the study and presenting a severe postpartum hemorrhage, not responding to the first-line of treatment (oxytocine + uterine massage + uterine revision). Women under the legal age will be able to participate in this study after authorization of a legal representative.

What does the study involve?
Patients will be randomly allocated to one of two groups. One group receives intrauterine balloon tamponade by condom catheter + usual treatment (misoprosotl) and the other receives usual treatment (misoprostol alone).

What are the possible benefits and risks of participating?
The intrauterine balloon tamponade seems to be a promising technique in the treatment of the postpartum hemorrhage. In order to avoid any “loss of luck” for the patients participating in the study, the intrauterine balloon tamponade will be given to patients belonging to the group receiving usual treatment.

What are the possible benefits and risks of participating?
There are no risks linked to the treatment by misoprostol, except the minor side effects of this product: nausea, vomiting, shiver, fever and abdominal pain (all of these are specified in the information note for the patients). The potential risk identified for the intrauterine balloon tamponade is a risk of infection. However, among 239 cases of intrauterine balloon tamponade tested in low-income countries, no case of infection was indicated. Furthermore, this study plans a preventive treatment by antibiotics to prevent this risk of infection.

Where is the study run from?
There are seven centers taking part in this trial :
Four in Cotonou:
1. Reference health center : Hôpital Mère-Enfant de la Lagune (HOMEL)
2. District hospital : Abomey-Calavi hospital
3. District hospital: Menontin hospital
4. Peripheral maternity of Missessin
Three in Bamako, Mali:
1. Reference health center of Commune V
2. Community health center of Sabalibougou I
3. Community health center of Torokorobougou

When is the study starting and how long is it expected to run for?
The study started in May 2013 and the approximate duration of the trial is 2 years.

Who is funding the study?
This study is promoted by the Institut de Recherche pour le Développement (IRD), Paris, France. All of the costs that this study will incur will be paid by IRD.

Who is the main contact?
Mrs Cecile Bodin, cecile.bodin@gmail.com
Dr Alexandre Dumont, alexandre.dumont@ird.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandre Dumont

ORCID ID

Contact details

IRD UMR 216
Faculté de pharmacie
4 avenue de l'observatoire
Paris
75006
France
alexandre.dumont@ird.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TIUHPPI v15/04/2013

Study information

Scientific title

Evaluation of intrauterine balloon tamponade efficacy with condom catheter and misoprostol (usual treatment) compared to misoprostol alone in the severe postpartum management hemorrhage management in Benin and Mali: a randomized controlled trial

Acronym

Condom PPH

Study hypothesis

The objective of this study is to demonstrate that the intrauterine tamponade by condom catheter allows reducing mortality and severe morbidity rate in case of severe postpartum hemorrhage.

Our hypothesis is that the mortality and severe morbidity rate (recourse to an invasive surgery) should reach 25% in the control group and 6% in the intervention group.

Ethics approval

1. France: Professional ethics and Ethics Consultative Committee of the Research Institute for Development (CCDE IRD), 29/01/2013
2. Mali: Ethics Committee of the Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS), 19/04/2013
3. Benin: Ethics and Research Committee of the Institute of the Biomedical Applied Sciences (ISBA) of Benin, 16/11/2013

Study design

International randomized controlled trial multicenter open-label in two parallel groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Gynecology-obstetrical / severe postpartum hemorrhage

Intervention

The first line of post-partum hemorrhage (PPH) management is an injection of oxytocin + the realisation of an uterine massage and a uterine revision. These 3 treatments have to be realised jointly. Thus, if neither the injection of oxytocin, nor the uterine massage and the uetrine revision allows to stop the PPH, the second line of PPH management has to be realized (administration of misoprostol or misoprostol + condom catheter tamponade.

Women presenting a postpartum hemorrhage resistant to oxytocin and first line laborers (uterine massage + uterine revision), will be randomized in order to receive:
1. The usual treatment to the posology of 5 tablets of Misoprostol 200 µg (intra-rectal) or 3 tablets of Misoprostol 200 µg (sub-lingual) immediately associated with an intrauterine balloon tamponade by condom-catheter
Or
2. Only the usual treatment to the posology of 5 tablets of Misoprostol 200 µg (intra-rectal) or 3 tablets of Misoprostol 200 µg (sub-lingual)

Intervention type

Drug

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measures

The primary outcome is a composite outcome: individual recourse to an invasive surgery (arterial ligatures, uterine compressive sutures, hysterectomy of haemostasis) and/or maternal death before the hospital release.

Secondary outcome measures

Each element of the composite primary outcome" is related to the point 1 and 2 only. So the secondary outcomes are formed by the 2 elements of the primary outcome measured separately and we will also measure three other outcomes: bleedings>1000 mL, necessity of a transfusion, necessity of a transfer.
1. Invasive intervention rate (arterial ligatures, uterine compressive sutures or hysterectomy of haemostasis): number of women having received an invasive intervention divided by the number of women included
2. Hospital maternal mortality rate (number of women included in the study and died before the hospital release divided by the number of inclusive women)
3. Bleeding > 1000 mL.
4. Necessity of a transfusion
5. Necessity of a transfer

Overall trial start date

01/05/2013

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The patients presenting the following criteria will be included in the study:
1. Having given birth by vaginal way, in one of the selected establishments
2. After 28 weeks of amenorrhea, or foetus > 1000 grams
3. Presenting a HPPI resisting the oxytocine and the first-line laborers (uterine massage + uterine revision)
4. Having given its oral consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

The target number of patient to be included in this trial is 110 women (55 in each group) with a risk α=0.05 and a power of 80 % with a bilateral formulation.

Participant exclusion criteria

The patients presenting the following criteria won’t be able to be included in the study:
1. Having given birth by caesarian
2. Presenting a contraindication or an allergy known about prostaglandines
3. Presenting an allergy to latex
4. Presenting a clinical Chorioamnionitis
5. Presenting a secondary postpartum hemorrhage, cervico-vaginal tears without uterine bleeding, an uterine break, or a placenta accreta

Recruitment start date

01/05/2013

Recruitment end date

30/04/2015

Locations

Countries of recruitment

Benin, Mali

Trial participating centre

IRD UMR 216
Paris
75006
France

Sponsor information

Organisation

Institute of Research for Development (Institut de Recherche pour le Développement) (IRD)

Sponsor details

IRD UMR 216
Faculté de pharmacie
4 avenue de l'observatoire
Paris
75006
France
cecile.bodin@ird.fr

Sponsor type

Research organisation

Website

http://www.umr216.fr/?lang=eng

Funders

Funder type

Not defined

Funder name

Institute of Research for Development (Institut de Recherche pour le Développement) (IRD), Paris (France) ref: TIUHPPI

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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