Pregnancy, Newborn HealthNCT01734434

Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems

An observational study of Pregnancy, Newborn Health, run by Novartis Vaccines at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Pregnancy, Newborn Health
How many people: 3,243 participants
Where: 10 sitesin 4 countries
Study dates: Nov 2012to Jan 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child, Adult, Older adult

Study population: Pregnant women of gestational age 24 weeks or more

Who may be able to join

Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment
Subject / subject's parents or a legal representative who has given written consent after the nature of the study has been explained according to local regulatory requirements
Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days

Who cannot join

None

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

South Africa4 sites

Children's Infectious Diseases Clinical Research Unit
Cape Town, 7500
Setshaba Research Centre
Gauteng, 0152
Synexus Research Centre
Gauteng
Respiratory and Meningeal Pathogens Research Unit
Soweto, Johannesburg

Other trials in South Africa

Panama3 sites

Policentro Juan Diaz
Panama City
Policentro Parque Lefevre
Panama City
Policlínica JJ Vallarino
Panama City

Other trials in Panama

Dominican Republic2 sites

Centro Sanitario de Santo Domingo
Santo Domingo
Maternidad Nuestra Senora de La Altagracia
Santo Domingo

Other trials in Dominican Republic

Mozambique1 site

CISM Manhica Health Research Centre
Manhiça

Other trials in Mozambique

About this study

Official title: A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems

This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened \& enrollment, delivery and 90 day infant follow-up. Data were collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contained the following standard questions which were asked at each visit, in addition to some visit-specific questions related to delivery and health status of infants up to 90 days of age. The standard questions related to the following aspects:

Logistics of transportation to the study site (type, time it takes, cost incurred)
Accessibility to a telephone/cell phone
Provisions of alternative child care during site visits if there are other children under the subject's care

Conditions: Pregnancy, Newborn Health
Keywords: Health care access, Pregnant women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01734434
Study group	Role	What they receive
Pregnant women		24 weeks or more of gestation

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Delivering at a Study Site.
The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
Measured: Baseline until average of 24 weeks
Percentage of Subjects Delivering at a Non-study Site.
The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.
Measured: Baseline until average of 24 weeks

Secondary outcomes (2)

Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.
Measured: Delivery to Day 90 post-delivery (Infant follow-up)
Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.
Measured: Delivery to Day 90 post-delivery (Infant follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jan 2015

First posted27 Nov 2012 (estimated)
Study startNov 2012
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pregnancy, Newborn HealthStudies 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: Observational
Observational model: Ecologic or community
Time perspective: Prospective
Enrolment: 3,243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01734434
Sponsor's protocol ID: V98_15OB
Status last verified: Jul 2017
First submitted: 22 Nov 2012
Last updated: 11 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.
Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.
PubMed 19106756
Madhi SA, Rivera LM, Saez-Llorens X, Menendez C, Carrim-Ganey N, Cotton MF, Katzman D, Luttig MM, Candelario R, Baker S, Roychoudhury M. Factors influencing access of pregnant women and their infants to their local healthcare system: a prospective, multi-centre, observational study. BMC Pregnancy Childbirth. 2018 Jan 15;18(1):29. doi: 10.1186/s12884-017-1655-3.
PubMed 29334920

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pregnancy, Newborn Health trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems
ClinicalTrials.gov ID: NCT01734434
Acronym / sponsor ID: V98_15OB
Conditions: Pregnancy, Newborn Health
Keywords: Health care access, Pregnant women
Study type: Observational
Recruitment status: Completed
Enrolment: 3,243 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Nov 2012
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 11 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Logistics of transportation to the study site (type, time it takes, cost incurred)
Accessibility to a telephone/cell phone
Provisions of alternative child care during site visits if there are other children under the subject's care

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pregnant women	–	–24 weeks or more of gestation

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Pregnant women of gestational age 24 weeks or more

Key inclusion criteria (3 listed)

Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment
Subject / subject's parents or a legal representative who has given written consent after the nature of the study has been explained according to local regulatory requirements
Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Subjects Delivering at a Study Site.
Time frame: Baseline until average of 24 weeks
The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
Percentage of Subjects Delivering at a Non-study Site.
Time frame: Baseline until average of 24 weeks
The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.

2 secondary outcomes

Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
Time frame: Delivery to Day 90 post-delivery (Infant follow-up)
Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
Time frame: Delivery to Day 90 post-delivery (Infant follow-up)

Results and safety

Results posted to the registry on 11 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maternal Subjects (Dominican Republic)	500	490
Maternal Subjects (Panama)	500	488
Maternal Subjects (South Africa)	1,992	1,863
Maternal Subjects (Mozambique)	251	228

Primary outcome: Percentage of Subjects Delivering at a Study Site.

Time frame: Baseline until average of 24 weeks. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	Maternal Subjects (Dominican Republic) n = 500	Maternal Subjects (Panama) n = 500	Maternal Subjects (South Africa) n = 1989	Maternal Subjects (Mozambique) n = 251
Subjects with known delivery information	99.20 (97.96 to 99.78)	100 (99.26 to 100)	99.65 (99.28 to 99.86)	100 (98.54 to 100)
Study site delivery	68.55 (64.26 to 72.61)	74.40 (70.34 to 78.17)	56.66 (54.44 to 58.86)	86.85 (82.03 to 90.77)

Population analysed: Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes.

Primary outcome: Percentage of Subjects Delivering at a Non-study Site.

Time frame: Baseline until average of 24 weeks. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	Maternal Subjects (Dominican Republic) n = 500	Maternal Subjects (Panama) n = 500	Maternal Subjects (South Africa) n = 1989	Maternal Subjects (Mozambique) n = 251
Subjects with known delivery information	99.20 (97.96 to 99.78)	100 (99.26 to 100)	99.65 (99.28 to 99.86)	100 (98.54 to 100)
Non-study healthcare facility	30.85 (26.81 to 35.12)	24.60 (20.88 to 28.62)	41.32 (39.14 to 43.53)	7.97 (4.93 to 12.04)
Home	0 (0 to 0)	0.40 (0.05 to 1.44)	0.76 (0.42 to 1.25)	2.79 (1.13 to 5.66)
Other	0 (0 to 0)	0 (0 to 0)	0.50 (0.24 to 0.93)	0.40 (0.01 to 2.20)
Unknown	0.60 (0.12 to 1.76)	0.60 (0.12 to 1.74)	0.76 (0.42 to 1.25)	1.99 (0.65 to 4.59)

Population analysed: Analysis was done on FAS.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maternal Subjects (Dominican Republic)	0 of 0	0 of 0	Not reported
Maternal Subjects (Panama)	0 of 0	0 of 0	Not reported
Maternal Subjects (South Africa)	0 of 0	0 of 0	Not reported
Maternal Subjects (Mozambique)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundWHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
BackgroundAssembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.
Background: PubMed 19106756Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.
Derived from this study: PubMed 29334920Madhi SA, Rivera LM, Saez-Llorens X, Menendez C, Carrim-Ganey N, Cotton MF, Katzman D, Luttig MM, Candelario R, Baker S, Roychoudhury M. Factors influencing access of pregnant women and their infants to their local healthcare system: a prospective, multi-centre, observational study. BMC Pregnancy Childbirth. 2018 Jan 15;18(1):29. doi: 10.1186/s12884-017-1655-3.

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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.

Novartis Vaccines and Diagnostics study chair

Novartis Vaccines

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, Newborn Health, run by Novartis Vaccines at 10 sites in 4 countries.

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 1 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Africa, Panama, Dominican Republic, Mozambique. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Delivering at a Study Site. (time frame: Baseline until average of 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01734434, which also lists 4 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 11 Dec 2018.