Intestinal Diseases, ParasiticPhase 4NCT01748929
Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
A Phase 4 study testing Albendazole in people with Intestinal Diseases, Parasitic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
Trial summary
Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Diseases, Parasitic
- What is being tested?
- Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,010 participants
- Where
- 1 sitePeru
- Study dates
- 24 Feb 2014to 16 Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Deliver at Hospital Iquitos
- Plan to reside in Iquitos or neighbouring area for the next 24 months
- Able to communicate in Spanish
Who cannot join
- Deliver multiples
- Delivery a stillborn or an infant with a serious congenital medical condition
- Transfered to another hospital prior to discharge
Trial locations and contacts
1 site in 1 country.
About this study
Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.
- Conditions
- Intestinal Diseases, Parasitic
- Being tested
- Albendazole, Placebo
- Keywords
- Global Health, Deworming, Postpartum, Soil-Transmitted Helminths, Pregnant Women
- Medical subject headings
- Intestinal Diseases, Parasitic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Experimental | single dose 400 mg tablet of albendazole Receives: Drug: Albendazole |
| Placebo | Placebo comparator | Placebo Manufactured by Hersil Laboratories in Lima, Peru Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean (± standard deviation) weight gain (kg)
Measured: Change between birth and six months of age
Secondary outcomes (7)
Infant morbidity
Measured: 1, 6, 12, 24 months following birth
Maternal hemoglobin levels and anemia
Measured: 1, 6, 12, 24 months following birth
Breastfeeding practices
The prevalence of current, exclusive, predominant and partial breastfeeding will be used to assess breastfeeding practices. In accordance with WHO criteria, infants will be considered as exclusively breastfed if they ingest only breast milk (excluding vitamins and medications); considered as predominantly breastfed if, in addition to breast milk, they also ingest water, juice, teas, vitamins or medications, and considered as partially breastfed if their primary nutrition source is other than breast milk.
Measured: 1, 6, 12, 24 months following birth
Maternal energy levels
Maternal energy levels will be measured using an adapted 5-item version of the Fatigue Assessment Scale (FAS) (Michielsen et al. 2004). This scale assesses symptoms of physical and cognitive fatigue.
Measured: 1, 6, 12, 24 months following birth
Maternal STH infection
Measured: 1 and 6 months following birth
Breast milk quality
Mean concentrations of key breast milk quality indicators (i.e. macronutrients, immunological factors, vitamins, and minerals) will be used to assess breast milk quality.
Measured: 1 and 6 months following birth
Breast milk quantity transferred from mother to infant
Measured: 1 and 6 months following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study start24 Feb 2014
- Primary completion13 Feb 2015
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intestinal Diseases, ParasiticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Theresa W Gyorkos, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMartin Casapia, MD, MPH, Principal investigator, Asociación Civil Selva Amazónica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748929
- Sponsor's protocol ID
- 12-198-GEN
- Status last verified
- Aug 2017
- First submitted
- 7 Dec 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mofid LS, Casapia M, Aguilar E, Silva H, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Blouin B, Razuri H, Pezo L, Gyorkos TW. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005098. doi: 10.1371/journal.pntd.0005098. eCollection 2017 Jan.
PubMed 28056024Mofid LS, Casapia M, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Gyorkos TW. Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period. BMJ Open. 2015 Jun 17;5(6):e008560. doi: 10.1136/bmjopen-2015-008560.
PubMed 26084556
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
- ClinicalTrials.gov ID
- NCT01748929
- Acronym / sponsor ID
- 12-198-GEN
- Conditions
- Intestinal Diseases, Parasitic
- Keywords
- Global Health, Deworming, Postpartum, Soil-Transmitted Helminths, Pregnant Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Experimental | Drug: Albendazolesingle dose 400 mg tablet of albendazole |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Manufactured by Hersil Laboratories in Lima, Peru |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Deliver at Hospital Iquitos
- Plan to reside in Iquitos or neighbouring area for the next 24 months
- Able to communicate in Spanish
Key exclusion criteria (3 listed)
- Deliver multiples
- Delivery a stillborn or an infant with a serious congenital medical condition
- Transfered to another hospital prior to discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole | Drug | Albendazole |
| Placebo | Drug | Placebo |
Primary outcome
Mean (± standard deviation) weight gain (kg)
Time frame: Change between birth and six months of age
7 secondary outcomes
Infant morbidity
Time frame: 1, 6, 12, 24 months following birth
Maternal hemoglobin levels and anemia
Time frame: 1, 6, 12, 24 months following birth
Breastfeeding practices
Time frame: 1, 6, 12, 24 months following birth
Maternal energy levels
Time frame: 1, 6, 12, 24 months following birth
Maternal STH infection
Time frame: 1 and 6 months following birth
Breast milk quality
Time frame: 1 and 6 months following birth
Breast milk quantity transferred from mother to infant
Time frame: 1 and 6 months following birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Derived from this study: PubMed 28056024Mofid LS, Casapia M, Aguilar E, Silva H, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Blouin B, Razuri H, Pezo L, Gyorkos TW. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005098. doi: 10.1371/journal.pntd.0005098. eCollection 2017 Jan.
- Derived from this study: PubMed 26084556Mofid LS, Casapia M, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Gyorkos TW. Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period. BMJ Open. 2015 Jun 17;5(6):e008560. doi: 10.1136/bmjopen-2015-008560.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa W Gyorkos, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Martin Casapia, MD, MPH principal investigator
Asociación Civil Selva Amazónica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albendazole in people with Intestinal Diseases, Parasitic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (± standard deviation) weight gain (kg) (time frame: Change between birth and six months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748929, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017; AzTrials last refreshed its copy on 26 Oct 2026.