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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The purpose of this clinical trial is to determine whether serial membrane sweeping at term is more effective than no membrane sweeping in promoting spontaneous onset of labor.
The primary research question is whether serial membrane sweeping increases the likelihood of birth before gestational age 41+3 with spontaneous onset of labor.
A total of 1536 participants will be randomized between gestational age 39+5 and 40+2 to either no membrane sweeping or up to three membrane sweepings performed 2-3 days apart.
Researchers will collect data from the electronic medical record and participants will be asked to complete a short daily questionnaire on pregnancy symptoms and, in the intervention group, their experience of membrane sweeping from randomization until birth. All participants will be asked to complete a follow-up questionnaire about their birth experience five weeks postpartum
Background and Objective:
Membrane sweeping is a simple mechanical procedure used at term to promote spontaneous onset of labor by stimulating local prostaglandin release. Although it is widely used and generally considered safe, evidence for its effectiveness is limited and of low certainty. The SWEEP trial is a multicenter randomized controlled trial designed to address this gap by investigating whether serial membrane sweeping starting between GA 39+5 and 40+2 increases the likelihood of spontaneous labor before GA 41+3 compared to no membrane sweeping.
Study design:
This is a pragmatic, open-label, multicenter, randomized controlled trial conducted in public antenatal clinics in Denmark. A total of 1536 pregnant women with low-risk, singleton pregnancies will be randomized between GA 39+5 and 40+2 to either: No membrane sweeping, or serial membrane sweeping with 2-3 days interval, max. three times.
Intervention and Procedures:
If possible, the first membrane sweeping will be performed during the routine antenatal visit at term. If not feasible, a separate consultation will be arranged. Two additional appointments will be scheduled as needed. Membrane sweeping is performed by inserting one or two fingers through the cervix and rotating them 2-5 times to separate the fetal membranes from the lower uterine segment. If the cervix is closed, cervical massage is performed externally with circular motions for approximately 15 seconds.
The intervention will continue until spontaneous labor begins or a maximum of three sweepings have been performed.
Participants in the control group will receive routine midwifery care but will be asked to avoid membrane sweeping until at least GA 41+3, unless medically indicated.
Inclusion criteria:
Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Exclusion criteria:
< 18 years of age Unable to speak and understand Danish Gestational age not determined by Crown-Rump-Length Previous cesarean section Ruptured membranes Painful contractions Vaginal bleeding more than bloody discharge Membrane sweeping performed within the last two weeks Already scheduled IOL or any known indication for IOL at or prior to GA 41+3 based on local or national guidelines Known low-lying placenta (placenta located <3 cm from the internal orifice verified by transvaginal ultrasound)
Outcomes:
The primary outcome is birth < GA 41+3 with spontaneous onset of labor.
Key secondary outcomes:
Risks and Side Effects:
There are no known serious risks associated with membrane sweeping for either the mother or baby.
Common and mild side effects may include:
Discomfort or mild pain during the procedure (the procedure can be stopped at any time upon request) Light spotting or brown discharge Braxton Hicks contractions
Informed Consent and Ethical Considerations:
Participants will receive both oral and written information in accordance with national and international ethical guidelines. Consent is obtained digitally via the REDCap platform using secure electronic signature technology.
Participants may withdraw consent at any time without consequence. All data are processed in accordance with the Danish Health Act and applicable GDPR regulations.
The study has been approved by the Regional Committees on Health Research Ethics for Central Denmark Region (journal number: 1-10-72-82-24 ) in accordance with Danish law and the Declaration of Helsinki.
Funding:
Funding for the trial is donated by:
Sundhedsdonationer from the Danish health insurance "danmark" with 7,000,000 DKK, The Health Research Foundation of Central Denmark Region with 100,000 DKK The Danish Association of Midwives with 45,931 DKK.
Additional funds will be sought to cover running costs during the trial. The investigators have no financial interests in the funding organizations.
Dissemination:
Study results will be published in international peer-reviewed journals and made publicly accessible in accordance with transparency requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No membrane sweeping | No Intervention | Participants allocated to the control group will receive standard antenatal care, which does not include membrane sweeping prior to gestational age 41+3. | |
| Membrane sweeping | Experimental | Participants allocated to the intervention group will receive standard anetnatal care plus serial membrane sweeping starting from the time of allocation at gestational age 39+5 to 40+2. A total of up to three membrane sweepings will be scheduled, each with an interval of 2-3 calendar days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Membrane sweeping | Procedure | Serial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation | Participants meet the primary outcome if they give birth before gestational age 41 weeks and 3 days, and labor starts spontaneously-defined as either prelabor rupture of membranes (PROM) or contractions leading to cervical dilation, without the use of medical or mechanical induction methods (including artificial rupture of membranes before 4 cm dilation) and without a cesarean section before labor begins | From randomization until time of birth. Assessed at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Undelivered at Gestational Age 41+3 | Still pregnant when entering the calendar date of GA 41+3 (deliveries at 41+3 counts as undelivered) | From randomization until time of birth. Assessed at birth. |
| Gestational Age at Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Method(s) used for Labor Induction | Method(s) used for labor induction:
| From date of randomization until time of birth. Assessed within 21 days. |
| More than One Induction Method used |
Inclusion Criteria:
Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofie Gyrup, PhD Student | Contact | +4522428032 | sofiegyrup@clin.au.dk | |
| Sidsel Boie, PhD, MD, Consultant | Contact | +4560636835 | sidselboie@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Julie Glavind, PhD, Associate Professor, MD | Aarhus University Hospital, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Not yet recruiting | Aarhus N | 8200 | Denmark |
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| Label | URL |
|---|---|
| The study's website | View source |
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Data are available from the corresponding author upon reasonable request and in accordance with Danish data protection regulations.
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Length of gestation at birth in days
| From randomization until time of birth. Assessed at birth |
| Randomization to Delivery Interval | Hours from randomization to birth | From date of randomization until the date of birth, assessed up to 21 days |
| Duration of Labor | Hours from selfreported starting time of contractions or spontaneous rupture of membranes till time of birth | From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth. |
| Duration of Active Labor | Minutes from active phase of labor registered in the electronic medical journal to time of birth or minutes from 4-6 cm of cervical dilation and painful contractions to time of birth. | From active phase of labor to time of birth |
| Induction Of Labor (IOL) | Labor started with any induction method including AROM <4 cm | From date of randomization until time of birth. Assessed within 21 days. |
| Indication for Induction of Labor | IOL due to:
| From date of randomization until time of birth. Assessed within 21 days. |
| Spontaneous Rupture of Membranes | Spontaneous rupture of membranes as primary labor onset occurring before contractions | From date of randomization until time of birth. Assessed within 21 days. |
| Use of Oxytocin Augmentation | Use of oxytocin augmentation during labor from more than 4 cm of cervical dilatation | From active phase of labor to time of birth |
| Intrapartum Temperature equal to or greater than 38.0 degrees Celsius | Two rectal temperature measurements of 38.0 degrees Celsius or higher, taken at least 30 minutes apart | From labor onset to time of birth |
| Epidural Analgesia During Labor | Administration of epidural from onset of labor till time of birth | From labor onset to time of birth |
| Mode of Delivery | Spontaneous vaginal delivery; no use of vacuum or forceps. Instrumental vaginal delivery: use of vacuum or forceps. Caesarean section: scheduled or acute | From onset of labor to time of birth |
| Early Labor Experience | Self-reported early labor experience measured using the validated Early Labor Experience Questionnaire (ELEQ); total and subscale scores calculated | 4-6 weeks postpartum |
| Childbirth Experience | Self-reported childbirth experience measured using the validated Childbirth Experience Questionnaire (CEQ); total and subscale scores calculated. | 4-6 weeks postpartum |
Use of >1 IOL method |
| From date of randomization until time of birth. Assessed within 21 days. |
| Intrapartum Administration of Sntibiotics | Any antibiotics during labor | From labor onset to time of birth |
| Endometritis Postpartum | Suspected or confirmed; requires hospital contact and antibiotics | From time of birth to 7 days postpartum |
| Maternal Mortality | Death of a female related to pregnancy or its management | Randomization to 42 days postpartum |
| Maternal Need for Intensive Care | Admission to an ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support for pregnancy or childbirth related complications | Randomization to 7 days postpartum |
| Maternal Length of Hospital Stay | Hours from admission to delivery ward to discharge | From time of birth to discharge from the hospital. Assessed within 42 days. |
| Postpartum hemorrhage | Total bleeding in ml. during delivery and up to 2 hours postpartum | From labor onset until 2 hours postpartum. |
| Uterine Rupture | Confirmed cases of uterine rupture | Randomization to time of birth |
| Abruptio Placentae | Confirmed cases of abruptio placentae | Randomization to time of birth |
| Decreased Fetal Movements | Hospital admission due to maternal concern over decreased fetal movements. Includes all cases leading to clinical assessment. | Randomization to time of birth |
| Telephone Consultations | Telephone consultations defined as number of inquiries by telephone regarding a clinical pregnancy question from the woman to the delivery unit or antenatal clinic | Randomization to admission for delivery |
| Outpatient Visits | Pregnancy-related outpatient visits not part of standard care or intervention | Randomization to admission for delivery |
| Hospital Admissions | Pregnancy-related hospital admissions not part of standard care or intervention. | Randomization to admission for delivery |
| Perinatal Death | Death within 7 days after birth, with specified type (antepartum, intrapartum, or neonatal), gestational age or age, and cause of death. | Randomization to 7 days postpartum |
| Serious Neonatal Morbidity | Composite of serious neonatal morbidity including NICU admission, need for respiratory support, Apgar <7 at 5 minutes, acidemia, or sepsis. | From time of birth until discharge from the hospital. Assessed within 42 days. |
| Admission to Neonatal Intensive Care Unit | Admission to NICU | From time of birth until discharge from the hospital or within the first 72 hours postpartum |
| Need for Respiratory Support | Need for respiratory support (intubation and mechanical ventilation, oxygen, continuous positive airway pressure (CPAP), or high-flow nasal cannula (HNFC)) within 72 hours after birth if admitted to a neonatal department. | From time of birth until discharge from the hospital or within the first 72 hours postpartum. |
| Apgar score < 7 at 5 minutes | Apgar score < 7 at 5 minutes | From time of birth until 5 minutes after birth. Assessed 5 minutes after birth. |
| Neonatal Acidemia | pH < 7.10 in a sample of umbilical cord arterial blood or neonatal blood obtained within the first hour after birth. | From time of birth to one hour postpartum |
| Neonatal Sepsis | Neonatal sepsis defined as antibiotic treatment continuously for 7 days minimum. | From time of birth until discharge from the hospital or within the first 72 hours postpartum |
| Membrane Sweeping Received Outside The Trial | Self-reported membrane sweeping performed outside the study protocol, e.g. by private provider or midwife via custom item in electronic questionnaire | From randomization until time of birth. Assessed 4-6 weeks postpartum |
| Stated Preference for Future Membrane Sweeping | Self-reported stated preference for receiving membrane sweeping in a future pregnancy, reported via custom item in electronic questionnaire. | 4-6 weeks postpartum |
| Term Pregnancy Symptoms | Daily self-reported presence and severity of predefined term pregnancy symptoms using a custom electronic questionnaire. | From date of randomization until date of birth. Assessed up to 15 days. |
| Experience of Membrane Sweeping | Self-reported experience of membrane sweeping using a visual analogue scale (VAS) and supplementary custom items. | From date of randomization until time of birth. Assessed up to three times within 7 days. |
| Number of membrane sweepings performed | Total number of membrane sweepings performed
| From randomization until time of birth. Assessed up to 12 days. |
| Number of cervical massages performed | Total number of cervical massages performed
| Randomization to time of birth |
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
|