- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594462
Contraception in Women With Sickle Cell Disease
Use of Etonogestrel-releasing Contraceptive Implant in Women With Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are 3,500 children born each year with sickle cell disease in Brazil. Almost three percent of Bahia population has sickle cell anemia, which is the most prevalent in Brazil (BRAGA, 2007).
Despite the high prevalence of sickle cell disease in our population, the best option Contraceptive for these women is still uncertain, based on low-quality studies (Haddad et al., 2012). Since this is a condition associated with numerous complications such as painful crises, splenic sequestration, marrow aplasia, among others, leads to frequent hospitalizations and high absenteeism rates. Women with sickle cell disease in reproductive age are exposed to non-planning pregnancies, which will cause high risk for maternal mortality (33%), and increased pictures of painful crises, and important maternal and newborn complications such as abortion, childbirth premature, thrombosis, among others (Andemariam, Browning, 2013). Therefore, there is a need to provide them with appropriate methods for effective reproductive planning.
Hormonal contraceptives with only progestogen, such as releasing implant etonogestrel (ENG), representing an option to reduce unwanted pregnancies, especially in patients at risk for venous thrombosis, such as patients with anemia sickle, because it doens´t interfere with the coagulation system (Conrad et al., 2004; Liedaagard etal., 2011). Thus, in addition to avoid an unwanted pregnancy, these methods have impact on reduction of maternal and fetal morbidity and mortality and neonatal known to be associated with pregnancies in women with sickle cell anemia (Santos et al., 2005).
The scientific literature is limited and scarce on the association between use of methods contraceptives in women with sickle cell disease and correlation with clinical complications such as seizures painful and anemia (Haddad et al., 2012).
The contraceptive implant etonogestrel is a reversibly progestogen-only contraceptive method, long lasting, highly effective, with high continuation rate. However, there is still no studies in women with sickle cell anemia in use thereof.
As it is a progestogen-only method, it does not increase the risk of thrombosis and may, as depot medroxyprogesterone acetate (Abood et al., 1997), reducing painful crises, with the advantage of high efficacy and long duration.
In this context, to increase adherence and whether a clinical benefit from use of the implant contraceptive releasing ENG, the contraceptive method more effectively isolated progestogen available in Brazil, in relation to painful crises and anemia among women with sickle cell disease, it is made of fundamental importance the development of a study in a city of high prevalence in Brazil.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil
- Bahiana School of Medicne and Public Health
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- University of Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women with homozygous sickle cell anemia ( hemoglobin SS ) , who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment.
- Age between 18 and 40 years-old ;
- Desire to use a long-term hormonal contraception
- Agreed to participate in the study after reading and signing the informed consent form.
Exclusion Criteria:
- Smoking, alcoholism or drug addiction ;
- Obesity , defined as body mass index (BMI ) greater than or equal to 30 kg / m2 ;
- contraindication to the use of isolated progestogen , according to WHO's eligibility criteria (WHO 2009)
- Desire to maintain standard of cyclic menstrual bleeding ;
- Allergy known local anesthetic ( lidocaine ) , once the implant is inserted after subdermal application of the local anesthetic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ENG-group
Twenty-five women with homozygous sickle cell anemia (hemoglobin SS), aged between 18-40 years-old, who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment; whom desire to use etonogestrel-releasing implant contraceptive without contraindications will be invited to inserted etonogestrel implant. Etonogestrel implant is a single implant progestogen-only, with 4 cm in length and 2 mm diameter containing 68 mg etonogestrel (3- ketodesogestrel), the active metabolite of desogestrel, involved in a ethylene vinyl acetate membrane (Huber, 1998), which is released continuously in bloodstream for three years. It will be inserted subdermal, on the inner face of non-dominant arm between the first and seventh day of the menstrual cycle. |
The etonogestrel implant will be inserted until the fifth day of the menstrual cycle .
Anthropometric measurements will be performed , blood pressure measurement , application of pain questionnaire for the last three months, and collection of fasting blood in our clinic .
After these measures , the ENG implant will be applied per researcher trained for such a procedure , following the recommendations outlined by the manufacturer.
Women are instructed to return after 3, 6, 9, 12 months, fasting 8h , when they will be measured anthropometric measurements , blood collection, and delivery of pain questionnaires and standard of menstrual bleeding.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of pain crises
Time Frame: 12 months
|
Self reported of pain quantity on a diary.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Safety as measured by hemoglobin, hepatic function
Time Frame: 12 months
|
Immediately before the implant insertion, peripheral blood samples (20 mL) were collected Blood samples were collected to evaluate complete blood count (reticulocytes, hemoglobin, platelets and leukocytes), hepatic function (Alkaline phosphatase, gamma-glutaryl transferase, amino alanine transferase, aspartate amino transferase, total bilirubin and its fractions), before , 6 and 12 months after the implant insertion.
|
12 months
|
Pain Scores on the Visual Analog Scale
Time Frame: 12 months
|
Pain intensity was measured by a visual scale, scored 0-10 (0=no pain until 10=worst pain) over each 3 months.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: MILENA B BRITO, MD, PhD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 458660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Sickle Cell Disease
-
Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Hilton...CompletedSickle Cell Disease | Sickle Cell Anemia in Children | Sickle Cell Thalassemia | Sickle Cell SC DiseaseUnited States
-
SangartCompletedSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseUnited Kingdom, France, Jamaica, Lebanon
-
Nova Laboratories LimitedCompletedSickle Cell Disease | Sickle Cell Hemoglobin C | Sickle Cell-beta-thalassemia | Sickle-Cell; Hemoglobin Disease, ThalassemiaUnited Kingdom, Jamaica
-
SangartWithdrawnSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseFrance, United Kingdom, Netherlands, Turkey, Bahrain, Belgium, Brazil, Lebanon, Qatar
-
University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Heart, Lung, and Blood Institute (NHLBI)TerminatedSickle Cell Anemia | Sickle Cell-hemoglobin C Disease | Sickle Cell-β0-thalassemiaUnited States
-
University of RegensburgRecruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | HbS Disease | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SGermany, Austria
-
Centre Hospitalier Intercommunal CreteilRecruitingSickle-Cell Disease Nos With CrisisFrance
-
HemaQuest Pharmaceuticals Inc.TerminatedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Egypt, Canada, Jamaica
-
HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica
Clinical Trials on etonogestrel-releasing implant contraceptive
-
University of Sao PauloCompleted
-
University of North Carolina, Chapel HillCompletedContraception | Postpartum | AdolescenceUnited States
-
Planned Parenthood of the St. Louis Region and...Merck Sharp & Dohme LLCCompleted
-
Indiana UniversitySusan Thompson Buffett FoundationCompleted
-
University of Colorado, DenverRecruiting
-
University of Colorado, DenverCompleted
-
University of California, DavisUniversity of Colorado, Denver; University of Pennsylvania; Merck Sharp & Dohme...RecruitingContraceptionUnited States
-
Montefiore Medical CenterSociety of Family PlanningCompletedContraception | Breastfeeding | Postpartum ContraceptionUnited States
-
Medical University of South CarolinaBayer; American College of Obstetricians and GynecologistsCompletedContraceptive UsageUnited States
-
Duke UniversityCompletedContinuation Rate of Contraceptive ImplantUnited States