MiMBa Pregnancy Registry

NCT04825782 | Unknown

• 1 other identifier: 20-056
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester. This will be a multi-country observational study and will be deployed in several field sites in Africa.

Conditions

Malaria in Pregnancy; Pregnancy Related; Congenital Anomaly

Keywords

Malaria; Pharmacovigilance; Pregnancy registry; Antimalarials

Outcome Measures

Primary Outcomes (3)

• Miscarriage

  Spontaneous pregnancy loss \<28 weeks gestation

  Between pregnancy identification and 28 weeks gestation

• Stillbirth

  A confirmed pregnancy lasting until 28 weeks of pregnancy, that results in the birth of a baby showing no signs of life

  Between pregnancy identification and delivery

• Major congenital anomalies

  Structural abnormality with surgical, medical or cosmetic importance that is present at birth

  Up to 12 months after birth

Secondary Outcomes (4)

• Maternal Mortality

  Up to 6 weeks post-delivery

• Neonatal mortality

  By 28 days post-delivery

• Low birthweight

  Within 48 hours of birth

• Prematurity

  At delivery

Study Arms (2)

Pregnant Women exposed to antimalarials during pregnancy

Pregnant women will be followed up prospectively. In certain sites, women of childbearing age (15-49 years) will be enrolled prior to pregnancy to ensure early pregnancy detection. Pregnancy and infant outcomes will be assessed systematically and recorded.

Pregnant Women unexposed to antimalarials during pregnancy

Pregnant women will be followed up prospectively. In certain sites, women of childbearing age (15-49 years) will be enrolled prior to pregnancy to ensure early pregnancy detection. Pregnancy and infant outcomes will be assessed systematically and recorded.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of childbearing age (40,000 to 60,000) and Pregnant Women - approximately 3000 to 5500 per year

You may qualify if:

• Pregnant or women of childbearing age (15-49 years)
• Resident within the defined catchment area. Residency status will be defined as having resided in the area for at least four months.
• Willingness to attend antenatal care and deliver in the study area.
• Willingness to give informed consent (and assent for non-pregnant WOCBAs under 18 years of age).

You may not qualify if:

• Refusal to participate or be followed up to the end of pregnancy. • Any medical, psychiatric, or social condition that would interfere with the ability to provide an accurate medical or drug history or the volunteer's ability to give informed consent (e.g. mentally disabled patients).

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Medicines for Malaria Venture: collaborator
• Worldwide Antimalarial Resistance Network: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, 40100, Kenya

RECRUITING

MeSH Terms

Conditions

Congenital Abnormalities; Malaria

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Feiko ter Kuile, MD, PhD

  Liverpool School of Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Stephanie Dellicour, PhD

CONTACT

+44 151 705 3287; Stephanie.dellicour@lstmed.ac.uk

Jenny Hill, PhD

CONTACT

+44 151 705 3287; Jenny.Hill@lstmed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: April 1, 2021
• Study Start: February 22, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)