Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

February 19, 2020 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.

In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.

Study Overview

Status

Recruiting

Conditions

Detailed Description

OBJECTIVES Main objective - To assess the safety of drugs used for IBD treatment both for pregnancy and for the offspring mainly focused on the risk of serious infections (from birth and in the first 4 years of life).

Specific objectives

  • To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with drugs used for the treatment of IBD.
  • To asses the developmental status of children born from IBD mothers during the first 4 years.
  • To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
  • To compare the prevalence of malformations in children exposed to drugs to treat IBD in utero with the prevalence in children who were not exposed.
  • To evaluate the relative risk of developing neoplasm in children exposed to drugs to treat IBD.

Inclusion criteria

  • Patients over 18 years of age diagnosed with IBD.
  • Confirmed pregnancy.
  • Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).

Exclusion criteria. - Patients who do not accept to participate in the study Study cohorts

- Biologics exposed cohort: Children born from mothers treated with biologic drugs (with or without immunomodulators) at any time during pregnancy or the three months before conception. Biologic drugs are IgG monoclonal antibodies able to cross the placenta.

  • Immunomodulators exposed cohort: Children born from mothers treated with immunomodulators (without biologics) during pregnancy or the three months before conception.
  • Non-exposed cohort: Children born from mothers treated neither with biologic drugs nor with immunomodulators at any time during pregnancy or the three months before conception.

Tasks and responsibilities:

IBD specialists from the participating centers will be responsible for identifying the patients, obtaining the informed consent and registering them in the database.

Each participating investigator will register all the demographic and clinical data of the mother at the time of entering in the study and will contact the pregnant woman at the end of first trimester, the end of second trimester, the end of third trimester and one month after delivery to prospectively include information about disease activity, treatments and serious adverse events (if any) during pregnancy and delivery. If the mother contacts the clinician (researcher) after the end of the first trimester but before the end of the second trimester of gestation, the case can be included and data up to the entry date registered retrospectively. In order to ensure data quality, patients who inform about the pregnancy after the end of the second trimester of gestation will be excluded.

After birth, the mother will be contacted every 3 months to include information about the child development and serious adverse events (mainly malformations, infections, hospital admissions or neoplasias such as developmental tumors). After consenting, contact information of the mother will be shared with the research team in Hospital Universitario de La Princesa in order to complete the information every 3 months. On a yearly basis, the mothers will provide the site investigator with the reports that support the information given in the remote contact. In addition, in the first visit after birth, mothers will be provided with the Ages and Stages Questionnaire (ASQ 3, annex 2) that should be completed during follow-up (2, 4, 6, 8, 9, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 42, 48 months of age). The mother should give the questionnaire she has completed once per year. External monitoring of cases included in the registry will also be performed by review of some cases selected at random by the research team of Hospital Universitario de La Princesa.

Definitions

  1. Disease location and phenotype: IBD location and phenotype will be defined according to the Montreal classification.
  2. Date of conception: It will be defined as the date of last menstruation before becoming pregnant.
  3. Smoking: Smoking status will be categorized as "non-smoker", "smoker", or "ex-smoker", and will be considered at the time of conception. Patients will be considered "smokers" if they smoked more than 7 cigarettes per week for at least 6 months prior to conception. Patients will be considered "ex-smokers" if they quit smoking before conception. Patients will be considered "non-smokers" if they never smoked.

3. Diagnosis of pregnancy: Elevated human chorionic gonadotropin (hCG) hormone in blood or urine (biochemical pregnancy).

4. Miscarriage: Natural death of an embryo or fetus before it is able to survive independently.

5. Elective abortion: The removal of an embryo or fetus from the uterus in order to end a pregnancy.

6. Comorbidities: Mother's diseases, with special mention to hypertension, diabetes mellitus, seizure disorders, thyroid disorders, allergic disorders, heart diseases, connective tissue diseases, autoimmune diseases, hepatitis.

7. Known risk factors for adverse pregnancy outcomes, including environmental or occupational exposure, among others.

8. Treatments: Treatments received by the mother in the 3 months before conception, during pregnancy and breastfeeding will be recorded.

9. Serious adverse events: In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered (see the definition of adverse events in the Annex 1 of the protocol). Nevertheless, the investigators have predefined the most frequent serious adverse events during pregnancy and in the offspring. In this respect, the main variable in our study will be the development of serious infection in the offspring (infection meeting criteria of serious adverse event).

9.1. Serious adverse events during pregnancy: Any event that meets the criteria of serious adverse event will be registered in the database. Some of the most frequent serious adverse events during pregnancy are specifically defined and inquired by the registry: abortion, stillbirth, growth retardation, serious infection, eclampsia, placenta previa, chorioamnionitis, or abruptio placenta. Abnormalities found in the 20th week ultrasound will be registered (although malformations should be confirmed after birth and included in the Serious Adverse Events section of the newborn). Fetal malformations that lead to abortion or stillbirth will be included as cause of abortion or cause of stillbirth in their specific sections (Serious adverse events of the mother).

9.2. Serious adverse events during delivery: Serious adverse events, such as instrumental delivery or preterm delivery will be registered in the Serious adverse events of the mother section. The admission for delivery will not be considered as a serious adverse event, but any event causing prolongation of the admission will be considered as a serious adverse event and registered in the specific section.

9.3. Serious adverse events in the newborns and children: Serious adverse events in the newborn and children, such as congenital malformations, admission to the intensive care unit, low birth weight, hypoxic-ischemic encephalopathy, neonatal stroke or low Apgar score, severe infections and tumors will be included.

10. Preterm delivery: Delivery before week 37 of gestation18, 19. 11. Low birth weight: <2,500 mg18, 19. 12. IBD activity: The IBD activity will be assessed at conception (when the physician is aware of the pregnancy) and in each trimester of gestation based on the Harvey-Bradshaw for CD and Partial Mayo Score for UC patients.

13. Low Apgar score: Apgar scores lower than 7 are considered low, and scores of 7 or higher are considered normal at ten minutes after birth20.

14. Serious infection: Only infections that meet the criteria of serious adverse event will be included. The inclusion of any infection, irrespective of its seriousness, would be very heterogeneous among investigators, leading to reporting bias which might affect the interpretation of the results. This variable will be the main outcome.

15. Developmental status: The developmental status will be assessed by the ASQ-3 questionnaire (annex 2). The mothers will complete the questionnaire at home and send the completed forms yearly to their treating clinicians.

Data collection and follow-up After the case is registered, four other visits will be recorded during pregnancy, coinciding with the routine visits of the patient for the follow-up of her disease. After delivery, the children will be followed-up until the age of 4 years. In case of multiple gestations, each child will be considered as a case with his/her own follow-up. Only live newborns will be considered cases. Abortions or stillbirths will be registered as mothers' adverse events. In multiple gestations, the number of fetuses affected by a certain serious adverse event will be indicated in the CRF. During the child's follow-up period, the mother (that is the patient, indeed) will be contacted remotely every-three months to complete information about child complications (if any). The visits over the study are described below. The variables included in the eCRF are listed in Annex 3.

  • Visit 0 (baseline): inclusion of patient in the study (after confirmed pregnancy) and registration of clinical data (characteristics of the disease, disease activity and treatments).
  • Visit 1 (end of first trimester of gestation): Updating of data related to treatment, disease activity and serious adverse events (if any).
  • Visit 2 (end of second trimester of gestation): Updating of data related to treatment, disease activity and serious adverse events (if any).
  • Visit 3 (end of third trimester of gestation): Updating of data related to treatment, disease activity and serious adverse events (if any).
  • Visit 4 (1 month after delivery): Updating of data related to treatment, disease activity and serious adverse events (if any). In addition, in this visit, the child will be registered in the database as a case. Information of the newborn, such as date of birth, sex, birth weight, Apgar score (at 5 and 10 minutes), vaccines, breastfeeding, serious adverse events, etc., will be included.
  • Visit 5 (3 months of age, 2 months after visit 4) to 20 (4 years of age): Updating of data related to children development, vaccines, breastfeeding, date of schooling, infections, hospitalizations, allergies or any other complications. The same data will be queried to the mother every-three months after the age of 4 years. Remote contacts will be allowed to complete the children information, as the investigators believe that this way of obtaining information will not have impact on the quality of data and will improve the adherence to the protocol. Nevertheless, once per year data should be confirmed with medical reports provided by the mothers.

Study data will be collected and managed using an electronic data capture tool (Research Electronic Data Capture [REDCap]1, 18, 19), which is hosted at Asociación Española de Gastroenterología21, a non-profit scientific and medical society focusing on gastroenterology. AEG provides this service free of charge, with the sole aim of promoting independent investigator-driven research. REDCap is a secure, web-based application designed to support data capture for research studies that provides the following: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.

Study Type

Observational

Enrollment (Anticipated)

1750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital de Granollers
        • Principal Investigator:
          • Victor Jair Morales, MD
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa
        • Contact:
          • María Chaparro
        • Principal Investigator:
          • María Chaparro, IP
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Cristina Alba, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Infanta Leonor
        • Principal Investigator:
          • Angel Ponferrada Díaz, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario de La Paz
        • Principal Investigator:
          • Mª Dolores Martín Arranz, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Doce de Octubre
        • Principal Investigator:
          • Pilar Martínez Montiel, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Gregorio Marañón
        • Principal Investigator:
          • Ignacio Marín Jiménez, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Sofía
        • Principal Investigator:
          • Noemí Manceñido Marcos, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Rey Juan carlos
        • Principal Investigator:
          • Carlos Castaño Milla, MD
      • Murcia, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Principal Investigator:
          • Antonio Sánchez Torres, MD
      • Murcia, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen del Rosell
        • Principal Investigator:
          • Ivan García Tercero, MD
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
          • Miguel Minguez
        • Principal Investigator:
          • Miguel Minguez
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
        • Recruiting
        • Complejo Hospitalario Santiago de Compostela
        • Contact:
          • Manuel Barreiro
        • Principal Investigator:
          • Manuel Barreiro
    • Andalucía
      • Córdoba, Andalucía, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Principal Investigator:
          • José Manuel Benítez, MD
      • Granada, Andalucía, Spain
        • Recruiting
        • Hospital Clinico Universitario San Cecilio
        • Principal Investigator:
          • María del Pilar Martínez Tirado, MD
      • Huelva, Andalucía, Spain
        • Not yet recruiting
        • Hospital Infanta Elena
        • Principal Investigator:
          • Aurora Talavera, MD
      • Huelva, Andalucía, Spain
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
        • Principal Investigator:
          • Juan María Vázquez Morón, MD
      • Málaga, Andalucía, Spain
        • Not yet recruiting
        • Hospital Regional Universitario de Málaga
        • Principal Investigator:
          • Victor Manuel Navas López, MD
      • Málaga, Andalucía, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Principal Investigator:
          • Guillermo Alcaín Martínez, MD
      • Sevilla, Andalucía, Spain
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • Eduardo Leo Carnerero, MD
      • Sevilla, Andalucía, Spain
        • Not yet recruiting
        • Hospital San Juan de Dios del Aljarafe
        • Principal Investigator:
          • Yolanda Torres, MD
    • Aragón
      • Huesca, Aragón, Spain
        • Not yet recruiting
        • Hospital San Jorge
        • Principal Investigator:
          • Miguel Montoro Huguet, MD
      • Zaragoza, Aragón, Spain
        • Not yet recruiting
        • Hopsital Universitario Miguel Servet
        • Principal Investigator:
          • Raquel Vicente Lidón, MD
      • Zaragoza, Aragón, Spain
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Principal Investigator:
          • Maite Arroyo Villarino, MD
      • Zaragoza, Aragón, Spain
        • Not yet recruiting
        • Hospital Royo Villanova
        • Principal Investigator:
          • Mara Charro Calvillo, Md
    • Asturias
      • Oviedo, Asturias, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Principal Investigator:
          • Sabino Riestra, MD
    • Baleares
      • Palma De Mallorca, Baleares, Spain
        • Recruiting
        • Hospital Universitario de Son Espases
        • Principal Investigator:
          • Daniel Ginard Vicens, MD
    • Canarias
      • Las Palmas De Gran Canaria, Canarias, Spain, 35010
        • Not yet recruiting
        • Hospital Doctor Negrin
        • Contact:
          • Daniel Ceballos
        • Principal Investigator:
          • Daniel Ceballos
      • Tenerife, Canarias, Spain
        • Recruiting
        • Hospital Universitario de Canarias
        • Principal Investigator:
          • Laura Ramos, MD
      • Tenerife, Canarias, Spain
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de la Candelaria
        • Principal Investigator:
          • Carlos Tardillo Marín, MD
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Principal Investigator:
          • Montse Rivero, MD
    • Castellón
      • Castellon de la Plana, Castellón, Spain
        • Not yet recruiting
        • Hospital General de Castellon
        • Principal Investigator:
          • Pedro Almela, MD
    • Castilla La Mancha
      • Ciudad Real, Castilla La Mancha, Spain
        • Not yet recruiting
        • Hospital Alcázar de San Juan
        • Principal Investigator:
          • Esther Berrardos, MD
      • Ciudad Real, Castilla La Mancha, Spain
        • Recruiting
        • Hospital General de Tomelloso
        • Principal Investigator:
          • Alfredo J Lucendo, Md
      • Ciudad Real, Castilla La Mancha, Spain
        • Recruiting
        • Hospital General Universitario De Ciudad Real
        • Principal Investigator:
          • Daniel Hervías Cruz, Md
      • Toledo, Castilla La Mancha, Spain
        • Not yet recruiting
        • Hospital Virgen De La Salud
        • Principal Investigator:
          • Concha Muñoz, Md
    • Castilla Y León
      • Burgos, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Santos Reyes
        • Principal Investigator:
          • Luis Hernández Villalba, MD
      • Burgos, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Universitario de Burgos
        • Principal Investigator:
          • Lara Arias, MD
      • Salamanca, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Universitario de Salamanca
        • Principal Investigator:
          • Fernando Muñoz, MD
      • Valladolid, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Clínico de Valladolid
        • Principal Investigator:
          • Noelia Alcaide, MD
      • Zamora, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Provincial de Zamora
        • Principal Investigator:
          • Paola María Fradejas, MD
      • Zamora, Castilla Y León, Spain
        • Not yet recruiting
        • Hospital Virgen de la Concha
        • Principal Investigator:
          • Ana María Fuentes Coronel, MD
    • Cataluña
      • Barcelona, Cataluña, Spain
        • Not yet recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Lucía Márquez Mosquera, MD
      • Barcelona, Cataluña, Spain
        • Recruiting
        • Hospital Universitario Clinic i Provincial
        • Principal Investigator:
          • Elena Ricart, MD
      • Barcelona, Cataluña, Spain
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Principal Investigator:
          • Alexandra Ruiz cerulla, MD
      • Barcelona, Cataluña, Spain
        • Not yet recruiting
        • Hospital Vall d´hebron
        • Principal Investigator:
          • Francesc Casellas Jordá, Md
      • Gerona, Cataluña, Spain
        • Not yet recruiting
        • Hospital Universitari Dr Josep Trueta
        • Principal Investigator:
          • David Busquets Casals, MD
      • Manresa, Cataluña, Spain
        • Not yet recruiting
        • Hospital Sant Joan de Déu
        • Principal Investigator:
          • Empar Sainz Arnau, MD
      • Tarragona, Cataluña, Spain
        • Not yet recruiting
        • Consorci Sanitari de Terrassa
        • Principal Investigator:
          • Marta Piqueras Cano, Md
      • Tarragona, Cataluña, Spain
        • Recruiting
        • Hospital Joan XXIII
        • Principal Investigator:
          • Margarita Menacho Viladot, MD
      • Tarragona, Cataluña, Spain
        • Not yet recruiting
        • Hospital Universitari Sant Joan de Reus
        • Principal Investigator:
          • Francisco J Martínez Cerezo, MD
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
        • Principal Investigator:
          • Ana Gutierrez, MD
      • Alicante, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Hospital Marina Baixa de Villajoyosa
        • Principal Investigator:
          • Antonio García Hérola, MD
      • Alicante, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Hospital Universitario San Juan
        • Principal Investigator:
          • Gloria García del Castillo, MD
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Not yet recruiting
        • Hospital General Universitario de Valencia
        • Principal Investigator:
          • José Mª Huguet, MD
      • Valencia, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Hospital Lluís Alcanyís de Xàtiva
        • Principal Investigator:
          • José Joaquín Ramírez Palanca, Md
      • Valencia, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Hospital Universitari i Politecnic La Fe
        • Principal Investigator:
          • Mariam Aguas, MD
    • Extremadura
      • Cáceres, Extremadura, Spain
        • Not yet recruiting
        • Hospital San Pedro Alcántara
        • Principal Investigator:
          • Carmen Dueñas, MD
    • Galicia
      • Ferrol, Galicia, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Ferrol
        • Principal Investigator:
          • Ana Echarri Piudo, MD
      • La Coruña, Galicia, Spain
        • Recruiting
        • Complexo Hospitalario Universitario de A Coruña
        • Principal Investigator:
          • Maria Teresa Diz-Lois Palomares, MD
      • Ourense, Galicia, Spain
        • Not yet recruiting
        • Complexo Hospitalario Universitario de Ourense
        • Principal Investigator:
          • Pablo Vega Villaamil, MD
      • Vigo, Galicia, Spain
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Principal Investigator:
          • Vicent Hernández Ramírez, MD
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain
        • Not yet recruiting
        • Hospital Comaral de Inca
        • Principal Investigator:
          • José Reyes Moreno, MD
    • Madrid
      • Alcorcón, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Principal Investigator:
          • Pilar López Serrano, MD
      • Fuenlabrada, Madrid, Spain
        • Recruiting
        • Hospital Universitario de Fuenlabrada
        • Principal Investigator:
          • Ivan Guerra, MD
      • Majadahonda, Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro
        • Principal Investigator:
          • Isabel Vera Mendoza, MD
      • Parla, Madrid, Spain
        • Not yet recruiting
        • Hosptial Universitario Infanta Cristina
        • Principal Investigator:
          • Belén Botella, MD
      • San Fernando De Henares, Madrid, Spain
        • Recruiting
        • Hospital del Henares
        • Principal Investigator:
          • Mari Carmen Rodríguez Grau, MD
      • Torrejón, Madrid, Spain
        • Recruiting
        • Hospital Universitario de Torrejon
        • Principal Investigator:
          • Manuel Va Domselaar, MD
    • Navarra
      • Pamplona, Navarra, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Principal Investigator:
          • Saioa Rubio, MD
    • Pais Vasco
      • Galdakao, Pais Vasco, Spain
        • Recruiting
        • Hospital de Galdakao-Usansolo
        • Principal Investigator:
          • Iago Rodríguez Lago, MD
    • País Vasco
      • Alava, País Vasco, Spain
        • Recruiting
        • Hospital Universitario de Alava
        • Principal Investigator:
          • Patricia Ramírez de la Piscina Urraca, Md
      • Donostia, País Vasco, Spain
        • Recruiting
        • Hospital Universitario de Donostia
        • Principal Investigator:
          • Luís Bujanda Ferández de Piérola, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.

Description

Inclusion Criteria:

  • Patients over 18 years of age diagnosed with IBD.
  • Confirmed pregnancy.
  • Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).

Exclusion Criteria:

• Patients who do not accept to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Biologics exposed cohort
Children born from mothers treated with biologic drugs (with or without immunomodulators) at any time during pregnancy or the three months before conception. Biologic drugs are IgG monoclonal antibodies able to cross the placenta.
Immunomodulators exposed cohort
Children born from mothers treated with immunomodulators (without biologics) during pregnancy or the three months before conception.
Non-exposed cohort
Children born from mothers treated neither with biologic drugs nor with immunomodulators at any time during pregnancy or the three months before conception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD.
Time Frame: 9 months
To assess the prevalence of complications related to drugs used for IBD treatment for pregnancy.
9 months
To calculate the incide rate of serious infections for the offspring (at eh age of 4 years) based on the medications used to treat IBD.
Time Frame: 4 years
To assess the prevalence of complications related to drugs used for IBD treatment for the offspring.
4 years
To calculate the incide rate of serious adverse events during pregnancy (evaluated at the end of pregnancy) based on the medications used to treat IBD.
Time Frame: 9 months
To asses the prevalence of complications related to drugs used for IBD treatment for pregnancy.
9 months
To calculate the incide rate of serious adverse events during offspring (at the age of 4 years) based on the medications used to treat IBD.
Time Frame: 4 years
To asses the prevalence of complications related to drugs used for IBD treatment for offspring mainly focused on the risck of serious infections at the age of 4 years.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. To calculate the Odds ratio of serious adverse events (including abortions) during pregnancy and delivery based on the drugs used for the treatment of IBD.
Time Frame: 4 years and 9 months
To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with drugs used for the treatment of IBD.
4 years and 9 months
3. To measure the developmental status of children born from IBD mothers with the ASQ-3 questionnaire during the first 4 years.
Time Frame: 4 years and 9 months
To asses the developmental status of children born from IBD mothers during the first 4 years.
4 years and 9 months
4. To calculate the Hazard ratio of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
Time Frame: 4 years and 9 months
To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
4 years and 9 months
5. To calculate the proportion of children with malformations and to compare the proportions between exposure groups (children exposed to biologics with those non exposed to these drugs).
Time Frame: 4 years and 9 months
To compare the prevalence of malformations in children exposed to biologics to treat IBD in utero with the prevalence in children who were not exposed
4 years and 9 months
6. To calculate the Hazard ratio of developing neoplasm in children exposed to drugs to treat IBD.
Time Frame: 4 years and 9 months
To evaluate the relative risk of developing neoplasm in children exposed to drugs to treat IBD.
4 years and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Collaborators

Spanish Agency of Medicines and Health Products

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2028

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIS-DUMBO-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

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