Failed Trial of Labor, Unspecified, With DeliveryNCT05333731
Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes
An observational study of Failed Trial of Labor, Unspecified, With Delivery and Failed VBAC (Vaginal Birth After Caesarean), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Failed Trial of Labor, Unspecified, With Delivery, Failed VBAC (Vaginal Birth After Caesarean), Prelabor Rupture of Membranes
- What is being tested?
- Oxytocin
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Adult
Study population: In the cesarean section group, the extra inclusion criteria includes: Only one prior low transverse uterine incision; Extra exclusion criteria: 1. With mutiple history of c esction; 2. Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision; 3. Short interpregnancy interval; 4. Prior uterine rupture or dehiscence, or cesarean scar pregnancy; 5. Evaluated fetal birth weight> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous
Who may be able to join
- Volunteers sign the informed consent;
- Age: 20-40 years;
- Singleton, a cephalic presentation;
- No contradiction to vaginal delivery;
- gestation: 37~42 weeks;
- With prelabor rupture of membrane.
Who cannot join
- Konwn contraindication to vaginal delivery or severe complications;
- Multiple gestation;
- Uterine malformation;
- Severe psychiatric disorder;
- Without family's support.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Tang Jinhai
About this study
Official title: To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study
This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled. Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. After 24 hours, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.
- Conditions
- Failed Trial of Labor, Unspecified, With Delivery, Failed VBAC (Vaginal Birth After Caesarean), Prelabor Rupture of Membranes, Failed Induction (of Labor) by Oxytocin
- Being tested
- Oxytocin
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean section group | In the cesarean section group, all the pregnant women had only one prior cesarean section. Receives: Drug: Oxytocin | |
| Non-cesarean section group | In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vignial birth rate
After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 Mar 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Failed Trial of Labor, Unspecified, With DeliveryStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333731
- Sponsor's protocol ID
- JPPTOLAC-02
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
PubMed 32080050Bellussi F, Livi A, Diglio J, Lenzi J, Magnani L, Pilu G. Timing of induction for term prelabor rupture of membranes and intravenous antibiotics. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100245. doi: 10.1016/j.ajogmf.2020.100245. Epub 2020 Oct 6.
PubMed 33451610Fishel Bartal M, Sibai BM, Ilan H, Fried M, Rahav R, Alexandroni H, Schushan Eisan I, Hendler I. Trial of labor after cesarean (TOLAC) in women with premature rupture of membranes. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2976-2982. doi: 10.1080/14767058.2019.1566312. Epub 2019 Jan 17.
PubMed 30652525Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
PubMed 28050900
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05333731
- Acronym / sponsor ID
- JPPTOLAC-02
- Conditions
- Failed Trial of Labor, Unspecified, With Delivery, Failed VBAC (Vaginal Birth After Caesarean), Prelabor Rupture of Membranes, Failed Induction (of Labor) by Oxytocin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled. Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. After 24 hours, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesarean section group | – | Drug: OxytocinIn the cesarean section group, all the pregnant women had only one prior cesarean section. |
| Non-cesarean section group | – | Drug: OxytocinIn the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- In the cesarean section group, the extra inclusion criteria includes: Only one prior low transverse uterine incision; Extra exclusion criteria: 1. With mutiple history of c esction; 2. Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision; 3. Short interpregnancy interval; 4. Prior uterine rupture or dehiscence, or cesarean scar pregnancy; 5. Evaluated fetal birth weight> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous
Key inclusion criteria (6 listed)
- Volunteers sign the informed consent;
- Age: 20-40 years;
- Singleton, a cephalic presentation;
- No contradiction to vaginal delivery;
- gestation: 37~42 weeks;
Key exclusion criteria (5 listed)
- Konwn contraindication to vaginal delivery or severe complications;
- Multiple gestation;
- Uterine malformation;
- Severe psychiatric disorder;
- Without family's support.
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 |
|---|---|---|
| OxytocinIn the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h. | Drug | Cesarean section group, Non-cesarean section group |
Primary outcome
Vignial birth rate
Time frame: 24 hours
After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 32080050Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
- Background: PubMed 33451610Bellussi F, Livi A, Diglio J, Lenzi J, Magnani L, Pilu G. Timing of induction for term prelabor rupture of membranes and intravenous antibiotics. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100245. doi: 10.1016/j.ajogmf.2020.100245. Epub 2020 Oct 6.
- Background: PubMed 30652525Fishel Bartal M, Sibai BM, Ilan H, Fried M, Rahav R, Alexandroni H, Schushan Eisan I, Hendler I. Trial of labor after cesarean (TOLAC) in women with premature rupture of membranes. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2976-2982. doi: 10.1080/14767058.2019.1566312. Epub 2019 Jan 17.
- Background: PubMed 28050900Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Trial of Labor, Unspecified, With Delivery and Failed VBAC (Vaginal Birth After Caesarean), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Ziyan, Ph.D (13512534017, zyjiangchm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vignial birth rate (time frame: 24 hours). 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 NCT05333731, 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 19 Apr 2022.