PregnancyNCT00703014
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
An observational study of Pregnancy and Neonates, run by Organon and Co.
Trial summary
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- What is being tested?
- Corifollitropin Alfa 150 μg, 200 IU RecFSH/Follitropin beta (Days 1 to 7) and 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 541 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2006to 15 Mar 2009
- 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 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with an ongoing pregnancy at least 10 weeks after ET in Base Trial P05787 (NCT00696800) were enrolled in this trial.
Who may be able to join
- Participants who received at least one dose of either Corifollitropin Alfa or
- Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
- Able and willing to give written informed consent.
Who cannot join
- None
About this study
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa)
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
Read the detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
- Being tested
- Corifollitropin Alfa 150 μg, 200 IU RecFSH/Follitropin beta (Days 1 to 7), Placebo for Corifollitropin Alfa, Placebo for RecFSH/Follitropin beta, 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin Alfa 150 μgDrug
In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
200 IU RecFSH/Follitropin beta (Days 1 to 7)Biological
Also called follitropin beta, Puregon®, Follistim®
In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Placebo for Corifollitropin AlfaDrug
In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.
Placebo for RecFSH/Follitropin betaDrug
In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
200 IU RecFSH/Follitropin beta (Days 8 to hCG)Biological
In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
GanirelixDrug
In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.
hCGBiological
In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
ProgesteroneBiological
In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
| Study group | Role | What they receive |
|---|---|---|
| Mothers Corifollitropin Alfa 150 µg | Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Receives: Drug: Corifollitropin Alfa 150 μg; Drug: Placebo for RecFSH/Follitropin beta; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone | |
| Mothers recFSH 200 IU | Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. Receives: Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7); Drug: Placebo for Corifollitropin Alfa; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Measured: Up to one day following delivery (up to 1 year)
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Measured: Up to one day following delivery (up to 1 year)
Number of Infants Born in Current Follow Up Trial Experiencing AEs
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Measured: Up to 12 weeks following delivery (up to 1 year)
Number of Infants in Current Follow Up Trial Experiencing SAEs
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Measured: Up to 12 weeks following delivery (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Measured: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Measured: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study start13 Jul 2006
- Primary completion18 Apr 2008
- Study completion15 Mar 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703014
- Sponsor's protocol ID
- P05712
- Other IDs
- 2004-004772-36, 38821, MK-8962-005, 2004
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
PubMed 22587997Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.
PubMed 22459628
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa)
- ClinicalTrials.gov ID
- NCT00703014
- Acronym / sponsor ID
- P05712
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2006 (actual)
- Primary completion
- 18 Apr 2008 (actual)
- Study completion
- 15 Mar 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
Detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers Corifollitropin Alfa 150 µg | – | Drug: Corifollitropin Alfa 150 μg, Drug: Placebo for RecFSH/Follitropin beta, Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: ProgesteroneParticipants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| Mothers recFSH 200 IU | – | Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7), Drug: Placebo for Corifollitropin Alfa, Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: ProgesteroneParticipants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with an ongoing pregnancy at least 10 weeks after ET in Base Trial P05787 (NCT00696800) were enrolled in this trial.
Key inclusion criteria (4 listed)
- Participants who received at least one dose of either Corifollitropin Alfa or
- Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
- Able and willing to give written informed consent.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corifollitropin Alfa 150 μgIn the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall. | Drug | Mothers Corifollitropin Alfa 150 µg |
| 200 IU RecFSH/Follitropin beta (Days 1 to 7)Also: follitropin beta, Puregon®, Follistim®In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. | Biological | Mothers recFSH 200 IU |
| Placebo for Corifollitropin AlfaIn the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall. | Drug | Mothers recFSH 200 IU |
| Placebo for RecFSH/Follitropin betaIn the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. | Drug | Mothers Corifollitropin Alfa 150 µg |
| 200 IU RecFSH/Follitropin beta (Days 8 to hCG)In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG. | Biological | Mothers Corifollitropin Alfa 150 µg, Mothers recFSH 200 IU |
| GanirelixIn the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG. | Drug | Mothers Corifollitropin Alfa 150 µg, Mothers recFSH 200 IU |
| hCGIn the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP | Biological | Mothers Corifollitropin Alfa 150 µg, Mothers recFSH 200 IU |
| ProgesteroneIn the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses. | Biological | Mothers Corifollitropin Alfa 150 µg, Mothers recFSH 200 IU |
Primary outcome
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
Time frame: Up to one day following delivery (up to 1 year)
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
Time frame: Up to one day following delivery (up to 1 year)
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Number of Infants Born in Current Follow Up Trial Experiencing AEs
Time frame: Up to 12 weeks following delivery (up to 1 year)
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Number of Infants in Current Follow Up Trial Experiencing SAEs
Time frame: Up to 12 weeks following delivery (up to 1 year)
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
Time frame: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
Time frame: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22587997Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
- Derived from this study: PubMed 22459628Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Neonates, run by Organon and Co.
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 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 24 Nov 2014). 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?
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) (time frame: Up to one day following delivery (up to 1 year)). The study lists 6 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 NCT00703014, 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 19 Sep 2024.